technique guide - spinemarketgroup

Technique Guide

P r e f a c e 1

N u Va s i v e ® P r o c e d u r a l S o l u t i o n 2

P r e - O p P a t i e n t P o s i t i o n i n g a n d P r e p a r a t i o n 3

V u e P o i n t ® I I S t a n d a r d Te c h n i q u e 5

E x p o s u r e 6

B o n e / P e d i c l e P r e p a r a t i o n 6

Ta p p i n g 9

S c r e w o r L a m i n a r H o o k S e l e c t i o n 10

D r i v e r S e l e c t i o n a n d S c r e w I n s e r t i o n / D i s e n g a g e m e n t 12

S c r e w H e a d A l i g n m e n t 14

R o d O p t i o n s 15

R o d P r e p a r a t i o n 16

R o d P l a c e m e n t 18

L a t e r a l O f f s e t O p t i o n s 18

R o d R e d u c t i o n 19

S e t S c r e w S e a t i n g a n d P r o v i s i o n a l T i g h t e n i n g 2 1

R o d A d j u s t m e n t 2 3

F i n a l T i g h t e n i n g 2 4

S u p p l e m e n t a l I n s t r u m e n t a t i o n 2 5

R e m o v a l 3 0

V u e P o i n t I I O c c i p i t a l Te c h n i q u e 3 1

V u e P o i n t I I O c c i p i t a l I n s t r u m e n t a t i o n O p t i o n s 3 2

O c c i p i t a l K e e l P l a t e P l a c e m e n t 3 3

O c c i p i t a l S c r e w P l a c e m e n t 3 5

A l t e r n a t e M e t h o d : A n g l e d I n s t r u m e n t a t i o n – O c c i p i t a l S c r e w P l a c e m e n t 3 7

C o n n e c t o r A r m T i g h t e n i n g 3 9

L o c k i n g D o w n t h e R o d 3 9

A l t e r n a t e M e t h o d : A n g l e d I n s t r u m e n t a t i o n – L o c k i n g D o w n t h e R o d 4 0

H i n g e d R o d 41

O c c i p i t a l E y e l e t C o n n e c t o r s 4 2

R e m o v a l 4 3

V u e P o i n t I I S y s t e m 4 5

C a t a l o g 5 4

I n s t r u c t i o n s f o r U s e 5 8

C O N T E N T S

VUEPOINT® I I FROM NUVASIVE ®

1

Dear Colleagues:

When the inaugural VuePoint® OCT posterior fixation system was released in 2008, we believed that we had reached a pinnacle in the evolution of posterior cervical surgery: an elegant, fully integrated solution to address even the most complex cervical pathology. The response from the spine surgery community was overwhelming, and the success of that system exceeded our hopes and expectations.

Over these past few years, posterior OCT techniques have continued to evolve rapidly, providing surgeons with increased options to treat complex disorders of the cranio-cervical junction, atlanto-axial complex, sub-axial spine, and cervico-thoracic junction. With evolving surgical techniques comes increased demand on the surgical implants.

This evolution took us back to the drawing board to design a more comprehensive system to answer these demands.

First, we compiled detailed critiques from a broad range of our surgeon colleagues in the field to identify opportunities to improve both the implants and the instruments. We also solicited feedback from the scrub nurses and O.R. techs who manage the trays day-to-day to ensure that the system works as well on the back table as it does in the surgeon’s hands, facilitating a seamless experience in the O.R. Armed with this information, a team of spine surgeons and engineers poured over every detail of form and function to optimize each element.

The result of this effort is the VuePoint II OCT system.

Every component in the system has been critically analyzed and refined. Screw thread design has been fine-tuned to optimize purchase in all types of bone. A generous variety of screw designs simplifies fixation. Color-coded, friction-fit polyaxial screw heads promote easy identification and handling, and favored angle screws in both 3.5 and 4.0mm diameters facilitate fixation across transition zones. For complex cranio-cervical cases, the Occipital Keel Plate remains low-profile for patient comfort, but is now top-loading and has rotational and lateral translation to optimize ease-of-use for implantation. Combined with the Hinged Rod, the process is even more user-friendly. All instrumentation has also been refined for greater utility and surgeon comfort.

New components have been added to enhance the spine surgeon’s ability to address greater and more complex instability and reduce deformity. Cobalt chrome rods (3.5mm) provide a robust alternative to standard titanium in settings where construct strength must be maximized. An ingenious screw-head-based Extra Rod Connector facilitates placement of dual rods across zones of maximal loading, reducing the potential risk of hardware failure across the cervico-thoracic junction in cases of extreme instability or kyphotic deformity. Tapered 3.5mm-to-5.5mm rods simplify the transition from occiput to cervical and from cervical to thoracic, allowing a seamless integration of VuePoint II with standard thoracolumbar fixation systems. Even complex deformity correction has been facilitated, with the addition of several rod reduction options included in the set.

We believe that VuePoint II represents a significant leap in the evolution of posterior spinal fixation. We are proud to present this system to our spine surgeon colleagues, and trust that your patients will benefit from the many advantages it has to offer.

VuePoint II: Adaptable, Junctional, Elegant.

Regards,

Christopher R. Brown, M.D. Assistant ProfessorDivision of Orthopaedic SurgeryDuke UniversityMedical Center Durham, NCUSA

Paul D. Sawin, M.D.American Board of Neurological Surgery Winter Park, FLUSA

Juan S. Uribe, M.D.Assistant ProfessorDirector, Spine SectionDirector, Biomechanical Laboratory Department of NeurosurgeryUniversity of South FloridaTampa, FL USA

Steven Vanni, D.O.Assistant Professor of Clinical Neurological Surgery and Orthopaedics and RehabilitationUniversity of Miami HospitalMiami, FLUSA

Neill Wright, M.D.Associate Professor of Neurological and Orthopaedic SurgeryWashington University School of Medicine St. Louis, MOUSA

P R E FA C E

2

N U VA S I V E ® P R O C E D U R A L S O L U T I O N

Osteocel® – Allograft Cellular Bone Matrix Osteocel is cancellous bone that is rich in viable cells,

combined with demineralized bone matrix from the same

donor, and cryogenically preserved to ensure cell viability is maintained.

The cells retained are a native population of bone-forming cells that are adherent to the

surface of the cancellous bone and consist of mesenchymal stem cells (MSCs)

and other cells further along the osteogenic lineage.

ACDFVuePoint® II

Biologics

CoRoent® Small Interlock™

• Zero-profile device implanted within the confines of the intervertebral disc space

• Surgical exposure limited to intervertebral disc• Fully integrated PEEK spacer and fixation

device simplifies implantation procedure• Large central aperture provides

ample space for fusion to occur

• Translational for ease of use• Fully junctional for simple

to complex cases• Elegant instrument designs

• Complete – osteogenic, osteoinductive, osteoconductive

• Physiologic – mimics biologic profile of autograft

• Consistent – each lot tested for cell count, viability, and activity

• Experienced – 150,000+ patients treated since 2005

NVM5 Spinal Cord Monitoring: SSEP and MEP

SSEPs and MEPs provide comprehensive motor and sensory spinal cord monitoring throughout the procedure. Multimodality monitoring can help identify possible ischemic events related to the ulnar nerve and brachial plexus as well as spinal cord impingement.1

NVM5 Nerve Root Monitoring: Free Run EMG

Continuously monitor for mechanical disturbances to nerve root structures with surgeon-directed audible and visual feedback. Applicable surgical steps for EMG monitoring include:

• Implant Sizing/Insertion • Decompression • Rod Insertion • Reduction• Distraction • Rod Compression • Final Tightening

Procedurally Integrated Neuromonitoring with NVM5®

1 Pelosi L, Lamb J, Grevitt M, et al. Combined monitoring of motor and somatosensory evoked potentials in orthopaedic spinal surgery. J Clin Neurophys 2002;113(7):1082-91.

SENSORY MONITORING MOTOR MONITORING NERVE ROOT MONITORING


3

Although patient positioning is always up to the discretion of the surgeon, care must be taken to position the patient with the neck in an anatomic alignment prior to instrumentation (Fig. 1). Most commonly, patients will be positioned prone, with the head in a Mayfield head-holder. Depending on the pathology and surgeon preference, the patient can be log-rolled into the prone position after intubation and line placement, or rotated on an OSI table. In any event, precautions should be used to maintain the neck in a natural alignment during positioning.

Prior to preparation of the operative site, a final positioning check should be done. The extremities should be well padded. The surgeon should verify the anatomic position of the neck relative to the chest, such that the patient is not instrumented in unacceptable flexion, extension, translation, or rotation. This is especially important with long-segment fusions or occiput-C1 or C1-C2 cases.

For cases involving the occiput or the upper cervical spine, the skin needs to be prepared up to the level of the inion. For cases involving the lower cervical spine, the skin needs to be prepared low enough for proper access. If intraoperative radiographs or fluoroscopy are going to be used, traction should be applied gently to the shoulders to facilitate imaging. If the patient has redundant or excess skin with neck folds in the operative field, 3-inch surgical tape may be helpful in pulling the skin taut. Tape can be applied in a crisscross pattern, starting lateral to the desired operative field and pulling down to the contralateral hip/buttock area.

For a complete list of intended uses, indications, device description, contraindications, warnings, and precautions, please refer to the Instructions for Use (IFU) in the back of this technique guide.

(Fig. 1)

ANESTHESIA

FLUORO

FLUOROMONITORS

NVM5®

PATIENT PREP FOR CERVICAL NEUROMONITORING WITH NVM5

During patient positioning, place the appropriate EMG, MEP and/or SSEP neuromonitoring electrodes on the patient.

P R E - O P PAT I E N T P O S I T I O N I N G A N D P R E PA R AT I O N

N O T E S

VUEPOINT® I I FROM NUVASIVE ®VUEPOINT® I I FROM NUVASIVE ®

N O T E S

V U E P O I N T ® I I S TA N DA R D T E C H N I Q U E

6

STEP 1:EXPOSURE

The surgical anatomy is exposed in the standard fashion. Care should be taken not to expose any facet joints that are not in the planned construct, as exposure of any additional facet may contribute to facet disruption and instability.

STEP 2:BONE/PEDICLE PREPARATION

Locate the desired entry point in the pedicle and perforate the cortex with an Awl (Fig. 2), or a high-speed burr.

A pilot hole can also be created, using a Straight Gearshift Probe or a Curved Gearshift Probe (Fig. 3).

A drill or gearshift can be used to reach desired depth and trajectory in bone for screw placement.

(Fig. 2)

(Fig. 3)

V U E P O I N T ® I I S TA N D A R D T E C H N I Q U E


7

STEP 2:BONE/PEDICLE PREPARATION (CONT.)

Drill:The 2.4mm Drill Bit can be used after perforating the outer cortex. The drill must always be used with the Drill Guide. Select the desired depth by pulling back on the knurled segment of the Drill Guide and placing the metal slide into the numbered slot labeled with the appropriate depth (Figs. 4, 5). Attach the Drill Bit to a Universal Handle or power drill (Fig. 6), insert the assembly through the barrel of the Drill Guide, and begin drilling. Once the Drill Bit is advanced to the preselected depth, a positive stop will prevent the Drill Bit from advancing any farther.

A designed safety feature of the VuePoint II OCT system is the positive stop on the Drill Guide, which can help to ensure that the drill is not accidentally advanced deeper than intended.

(Fig. 4)

(Fig. 6)

(Fig. 5)


8

STEP 2:BONE/PEDICLE PREPARATION (CONT.)

Gearshift:Gearshifts can also be used to perforate the outer cortex. Gearshifts are 1mm wide at the distal tip, and they are marked every 5mm of length (Figs. 7, 8). Slowly twist and drive the gearshift to desired depth. The profile/shape of the gearshift is 2.1mm square. If turned more than 90° in either direction while making the hole, this instrument will produce a 3mm hole.

Inspect the integrity of the pedicle walls by placing a Ball Tip Probe into the pilot hole and palpating the pedicle wall on all sides (Fig. 9). The Depth Gauge can be used to check the depth of the prepared hole.

(Fig. 8)

(Fig. 7)

(Fig. 8a)

(Fig. 7a)

(Fig. 9)



9

STEP 3: TAPPING

All Multi Axial Screws are self-tapping; however, if preliminary tapping is required, taps are available to prepare the threads for 3.5mm and 4.0mm diameter screws (Fig. 10). The Adjustable Tap Sleeve may be used to serve as a positive depth stop and a tissue protection sleeve. To use the Tap Sleeve, select the desired depth by pulling back on the knurled segment of the Tap Sleeve and placing the metal slide into the numbered slot, labeled with the appropriate depth (Fig. 11). Once this is done, slide the tap of the selected diameter into the sleeve. The sleeve will be retained on the Tap Shaft with an internal friction washer to prevent accidental disassembly (Fig. 12).

(Fig. 10)

Note

The Tap Sleeve can tap depths ranging from 10mm to 24mm.

Note

The 3.5mm Tap is undersized by 0.5mm and has an actual diameter of 3.0mm; the 4.0mm Tap is undersized by 0.5mm and has an actual diameter of 3.5mm.

Note

Tap Shafts have a color-coded band to match the appropriate screw diameter: the magenta colored 3.5mm Tap matches the magenta colored 3.5mm Multi Axial Screw heads; the aqua-colored 4.0mm Tap matches the aqua-colored 4.0mm Multi Axial Screw heads.

Note

A 4.5mm Tap Shaft is not available in the set, although we offer 4.5mm Multi Axial Screws. 4.5mm screws are intended to be rescue screws only.

V U E P O I N T ® I I S TA N D A R D T E C H N I Q U EV U E P O I N T ® I I S TA N D A R D T E C H N I Q U E

(Fig. 11)

(Fig. 12)

10

STEP 4:SCREW OR LAMINAR HOOK SELECTION

Note: Three Multi Axial Screw options are available:

1. Multi Axial Screw: 40/40° of angulation (Fig. 13)a. Offers an 80° conical sweep.b. Offered in 3.5mm, 4.0mm, and 4.5mm diameters.

2. Favored Angle Screw: 55/10° of angulation (Fig. 14)a. Up to 55° of favored angulation.b. The silver half of the bi-colored screw head provides a

visual indication of the favored angle orientation.c. Offered in 3.5mm and 4.0mm diameters.

3. Partially Threaded (Favored Angle) Screw: 55/10° of angulation (Fig. 15)

a. Smooth portion helps protect nerve roots and soft tissue if the tulip is left proud of the bone surface.

b. Last 10mm of proximal portion of the screw shaft is smooth (unthreaded).

c. The silver half of the bi-colored screw head provides a visual indication of the favored angle orientation.

d. Offered in 3.5mm diameter.

All three Multi Axial Screw types offer friction-fit screw heads to provide superior alignment control (Fig. 16).

(Fig. 16)

(Fig. 13)

(Fig. 14)

(Fig. 15)

MULTI AXIAL

FAVORED ANGLE

PARTIALLYTHREADED



11

STEP 4: SCREW OR LAMINAR HOOK SELECTION (CONT.)

Hook Insertion Select the appropriate Laminar Hook size, based on the claw length required. Hooks are available in 6.0mm (Fig. 17) and 8.0mm (Fig. 18), sizing which refers to the hook shelf length.

Engage the Laminar Hook with the Threaded Driver and turn the thumbwheel clockwise until desired retention is achieved (Figs. 19, 20).

(Fig. 17) (Fig. 18)

(Fig. 19)

(Fig. 20)


12

STEP 5:DRIVER SELECTION AND SCREW INSERTION/DISENGAGEMENT

With the pedicle prepared and the appropriate screw length determined, attach a Multi Axial Screw to the Tapered Hex Drive Shaft, Threaded Driver, or Stab-n-Go Driver.

Tapered Hex Driver Attach a Tapered Hex Drive Shaft to a Universal Handle (Fig. 21). This driver will engage, pick up, and hold a Multi Axial Screw using the tapered hex tip (Fig. 22). Retention force of this driver is proportional to the axial force applied to the shaft when engaging the screw.

To Disengage: Place the screw in the screw hole and pull the driver off the Multi Axial Screw. Repeat these steps for all screw placement sites.

Threaded DriverTo Engage: Insert the Threaded Driver tip into the Multi Axial Screw Head (Fig. 23). Ensure the driver fits snug into the head and the screw trajectory remains neutral to the driver shaft. Advance the threaded tip to the head of the screw.

Secure the engagement of the driver and screw head by turning the long slim knurled section of the threaded outer sleeve of the instrument clockwise into the screw head (Fig. 24). It is fully seated in the head when resistance is felt.

To Disengage: Turn the long, slim knurled section of the driver counterclockwise. Repeat these steps for all screw placements.

(Fig. 23)

(Fig. 24)

(Fig. 21)

(Fig. 22)



13

STEP 5:DRIVER SELECTION AND SCREW INSERTION/DISENGAGEMENT (CONT.)

Stab-n-Go DriverTo Engage: Attach a Stab-n-Go Driver shaft to a Universal Handle. This driver will engage, pick up, and hold a Multi Axial Screw (Fig. 25), and retain the screw using a spring clip (Fig. 26). This ensures that the retention force between the driver and the screw remains consistent and independent from the amount of force that is applied to the driver when it engages the screw. Place the screw in the prepared screw hole (Fig. 27).

To Disengage: Simply pull up and apply a rolling motion, or gently rock to disengage.

(Fig. 27)

Note

When using the Stab-n-Go Driver, do not bottom out the tulip on the bone, as the tulip will tilt, and the driver may jam or be more difficult to disengage from the inside of the screw.

Note

Do not insert the Multi Axial Screws so tightly and deeply that the multi axial feature is lost.

Note

If the screw is bottomed out in the bone and there is difficulty disengaging the driver, turn the screw back ¼ turn. This will allow the driver to disengage more easily.

(Fig. 26)

(Fig. 25)

NVM5® MEP: MOTOR PATHWAY MONITORING

After screws are inserted, a subsequent MEP reading may be taken to verify motor pathway integrity.


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STEP 6:SCREW HEAD ALIGNMENT

Alignment ToolThe Alignment Tool can be used to align the screw heads and facilitate easy rod placement (Figs. 28, 29). A key design feature of the VuePoint II Tulip Screws is the offer of a friction-fit feature. This feature helps eliminate head flop, which is potentially troublesome when aligning a multi-level construct.

Note

One of the advantages of the VuePoint II OCT system is providing the surgeon a continuous visualization of the direction of Favored Angle Screws from his/her VuePoint, or from the top-down (Fig. 30). When using a Favored Angle Screw, denoted by the bi-colored screw head, always orient the silver half of the screw head in the direction which facilitates the most angulation. Favored Angle Screws offer up to 55° of angulation.

(Fig. 28)

(Fig. 29)

(Fig. 30)



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STEP 7:ROD OPTIONS

Several rod options are available in the VuePoint II set:

3.5mm Diameter Rods (Titanium unless otherwise noted):• 60mm straight (Fig. 31)• 80mm pre-lordosed (Fig. 32)• 120mm straight (also available in Cobalt Chrome*)

(Fig. 33)• 240mm straight (also available in Cobalt Chrome*)

(Fig. 34)• Transition Rod (also available in Cobalt Chrome*)

(203mm of ø3.5mm to 265mm of ø5.5mm) (Fig. 35)• Hinged Rod (90mm occipital and 210mm sub-axial)

(Fig. 36)• 45° Precurved Occipital Rod (also available in Cobalt

Chrome*) (90mm occipital and 210mm subaxial) – measured from middle of curve (Fig. 37)

* Cobalt Chrome (120mm, 240mm, transition, and precurved rods) offered as specials upon request.

(Fig. 31) (Fig. 32)

(Fig. 33)

(Fig. 34)

(Fig. 36)

(Fig. 35)

(Fig. 37)


16

STEP 8:ROD PREPARATION

Rod Template lengths of 120mm and 240mm may be used to determine the length and overall curvature of the rod (Fig. 38).

Cutting the RodUse the Rod Cutter (Fig. 39) to cut the rod to the appropriate length. The VuePoint II rods are anodized with a longitudinal line on one side and length markings on the other. The length markings can be used to conveniently identify the proper cut location, based on templating or other measurements.

The Rod Cutter offers three cutting locations:

1. ScissorThe scissor portion of the cutter is recommended for primary cuts as well as to address in-situ cutting requirements (Fig. 40).

2. Center HoleThe hole in the cutter may be used for primary cuts (Fig. 41).

3. Side SlotThe side slot cutting feature is used to simultaneously cut and swage the Adjustable Cross Connector Rod (Fig. 42). See Adjustable Cross Connector technique on page 23.

(Fig. 38)

(Fig. 39)

(Fig. 41)

(Fig. 40)

(Fig. 42)



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STEP 8:ROD PREPARATION (CONT.)

Rod BendingThe Rod Bender can be used to contour the 3.5mm rod to best match the desired curvature of the spine. The longitudinal line anodized on the rod surface can be used to help ensure all of the introduced bends are in the same plane.

In-Situ BendingIn-Situ Benders can be used to achieve three types of bends:

1. Tube Benders: Create sharp occipital bends using the proximal ends of the benders. This is done by inserting the ends of the rod into the proximal bores of the benders until the desired location of the bend is located in the space between benders. Thumbwheels can then be tightened to lock the rod in place for proper bend location. The rod can now be bent by applying force (Fig. 43).

2. In-Situ Benders: The hooks at the distal ends of the benders can be used to bend the rod in-situ. To accomplish this, slide the hooks of both In-Situ Benders underneath the rod in a way that provides proper leverage. The bend may then be introduced by tilting the handles toward or away from each other, depending on the desired bend (Fig. 44).

3. Transverse Holes: The transverse holes at either end of the instrument can be used to introduce more complex bends. They can be used by themselves or in conjunction with the Tube Bender functionality (Fig. 45).

Note

The bend radius can be controlled by changing the distance between the benders. The greater the distance, the greater the bend radius will be produced, and vice versa. Regardless of the distance between the benders, the location of the bend will always be the mid-point between them.

(Fig. 43)

(Fig. 44)

(Fig. 45)

(Fig. 43a)


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STEP 9:ROD PLACEMENT

Insert the rod into the Multi Axial Screw Heads, Hook Heads, and Occipital Keel Plate using the Holding Forceps or Rod Gripper. The Rod Gripper may be used if more control over the rod is desired (Fig. 46).

STEP 10:LATERAL OFFSET OPTIONS

Two Offset Lateral Connector OptionsTwo sizes are available, 11mm (Fig. 47) and 25mm (Fig. 48), which allow for 8mm and 23mm of medial-lateral adjustment, respectively. The connectors are open in design, which allows the intraoperative flexibility of attaching a Lateral Connector to a rod in-situ, without having to extract the entire rod (Fig. 49).

Acute-Angle Offset Connector OptionThe Acute-Angle Offset Connector offers a 30mm rod extension angled at 45° to address difficult pathologies or surgeon requirements (Fig. 50).

Note

The long 25mm and 30mm Offset Connectors can be cut to size with the Rod Cutter, depending on the required length.

(Fig. 47)

(Fig. 46)

(Fig. 49)

(Fig. 48)

(Fig. 50)



Final tighten the Offset Connector Set Screw by engaging the Counter-Torque over the Offset Connector, place the Final Tightening Shaft (Black) and Final Tightening Torque Limiting Handle assembly through the Counter-Torque. A tactile audible “click” signifies that the Set Screw is locked at the recommended 26 in./lb. (3 N-m).

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STEP 11:ROD REDUCTION

If rod reduction is required before placing the Set Screw, the rod can be reduced to the bottom of the Multi Axial Screw or Hook Head by employing either the Reduction Tower (Fig. 51) or Rocker.

Reduction Tower To Engage: Back the wheel all the way out by turning counterclockwise. To snap the distal tip of the Reduction Tower onto a Tulip Screw Head, Hook Head, or Occipital Tulip Head, advance the wheel a few turns clockwise until the instrument grips the tulip (Fig. 52).

Spin the wheel clockwise to attain reduction and get the rod seated, as desired (Fig. 53).

A Set Screw can be passed through the center bore of the instrument and started in the tulip using either a Tapered Hex Driver or the Set Screw Repeater (Fig. 54).

To Disengage: Turn the wheel counterclockwise until it fully disengages from the Tulip Screw Head, Hook Head, or Occipital Tulip Head.

Note

Only one screw can be loaded on the Set Screw Repeater when inserted through the Reduction Tower.

(Fig. 52)

(Fig. 51)

(Fig. 53) (Fig. 54)


20

STEP 11:ROD REDUCTION (CONT.)

RockerTo Engage: Slide the Rocker over the flats of the tulip until the prongs of the Rocker are lined up with the oval depressions in the tulip. Then tilt the Rocker lightly to firmly engage the tulip.1. Once the Rocker is engaged, tilt it to reduce the rod to the

bottom of the saddle (Fig. 55).2. Insert the Tapered Hex Driver or Repeater with an attached

Set Screw onto the tulip head, hold the Rocker in position, and provisionally tighten down the Set Screw (Fig. 56).

To Disengage: Push the Rocker downward to disengage the divots; then slide it off of the tulip in either cephalad or caudal direction.

Counter-Torque/Rod PusherThe Counter-Torque can be utilized as a rod pusher by aligning it over the tulip and pushing the rod down. The tulip will prevent the instrument from slipping. A Set Screw can be passed through on the Final Tightening Shaft (Black) and provisionally tightened (Fig. 57).

(Fig. 55)

(Fig. 56)

(Fig. 57)

Note

The Rocker has an angled distal tip, allowing you to avoid unnecessary contact with the margins of the surgical exposure.



21

STEP 12:SET SCREW SEATING AND PROVISIONAL TIGHTENING

Once the rod is positioned, the construct can be secured using Set Screws. Engage a Set Screw using the Tapered Hex Driver (Fig. 58) or Repeater (Fig. 59). Then thread the Set Screw into the Multi Axial Screw or Hook Head and provisionally tighten down.

Note

Turning the Set Screw ¼ to ½ turn backward will help prevent cross-threading. It may also give you an audible click and drop into place. After this, turn clockwise to drive into screw.

(Fig. 59)

Note

If necessary, align the black timing marks on the Set Screw and tulip head prior to insertion, to position the mating threads in their proper orientation in order to thread the Set Screw more easily.

(Fig. 58)


22

The Repeater Allows preload of up to eight Set Screws. Be sure you load Set Screws with the black timing marks facing up.

To Load Set Screws: Place the tip of the Repeater into the hexalobe feature of the Set Screw, and slowly rotate the driver while applying moderate downward pressure on the screw (Fig. 60). (Be sure you load the Set Screws with black timing marks facing up).

When you feel the Repeater pop through the Set Screw (tactile feel), you may repeat this step for the next Set Screw (Fig. 60).

When the desired number of Set Screws are loaded, make sure that the silver tip of the Repeater can be seen protruding below the bottom of the last Set Screw. If the silver tip does not protrude, push on the last Set Screw (toward handle) until the tip protrudes.

Place the distal most Set Screw into a Multi Axial Screw Head or Hook Head. Advance the Set Screw using a 3-finger tightening technique to provisionally tighten, continue turning through resistance (Fig. 61). This will cause the driver to deliver the Set Screw into the tulip and release itself. Do not pull up on the Set Screw Repeater to disengage.

Note

If the tip continues to sink below the bottom surface of the screw, do not utilize the instrument as it may not be functioning properly. Contact NuVasive® Customer Service and return the instrument.

(Fig. 60)

STEP 12:SET SCREW SEATING AND PROVISIONAL TIGHTENING (CONT.)

(Fig. 61)

CAUTIONExercise caution when using the Set Screw Repeater as pulling up on Set Screw Repeater may cause screw pullout or extreme force on the spine.



23

STEP 13:ROD ADJUSTMENT

In-Situ Rod BenderIn-Situ Rod contouring may be performed with In-Situ Benders prior to final Set Screw tightening. The In-Situ Benders are used to improve or adjust kyphosis and lordosis (Fig. 62).

CompressorIf compression is required, provisionally tighten a Set Screw on one side of the motion segment, leaving the other Set Screw loose to allow movement along the rod (Fig. 63). Place the Compressor on the outermost part of both Multi Axial Screws, relative to the construct. With the Compressor properly engaged, deliver the appropriate amount of compression by squeezing the instrument handles, and then provisionally tighten the loose Set Screw to hold the construct in position prior to final tightening.

DistractorIf distraction is required, provisionally tighten the Set Screw on one side of the motion segment, leaving the other Set Screw loose to allow movement along the rod. Place the Distractor on the innermost part of the Multi Axial Screws, relative to the construct. With the instrument properly engaged, deliver the appropriate amount of distraction by squeezing the instrument handles, and then provisionally tighten the loose Set Screw to hold the construct in position prior to final tightening (Fig. 64).

(Fig. 64)

(Fig. 63)

(Fig. 62)

(Fig. 62a)

CERVICAL NEUROMONITORING WITH NVM5®

Continue to monitor for nerve root events (EMG) and shifts from motor (MEP) and sensory (SSEP) baselines during construct adjustments and alignment.


24

(Fig. 67)

STEP 14:FINAL TIGHTENING

Attach the Final Tightening Shaft (Black), which is colored black, to the Final Tightening Torque Limiting Handle (Fig. 65). Seat the Counter-Torque over a Multi Axial Screw, Hook Head, or Keel Plate Tulip Head, and slide the Final Tightening Torque Limiting Handle and Final Tightening Shaft (Black) assembly through the canal of the Counter-Torque (Fig. 66). Engage the driver into the provisionally tightened Set Screw, and begin turning the Set Screw clockwise until the Final Tightening Torque Limiting Handle torques out. A tactile and audible “click” confirms that the Set Screw is locked at the recommended 26 in./lb. (3 N-m) (Fig. 67).

(Fig. 65)

(Fig. 66)



25

(Fig. 68)

(Fig. 69)

STEP 15:SUPPLEMENTAL INSTRUMENTATION

Cross Connector PlacementOnce all Multi Axial Screws, Rods, Hooks, Keel Plate, and Occipital Bone Screws have had final tightening performed, further torsional support may be added to the construct with the placement of Cross Connectors.

You have two options:

1. Adjustable Tulip to Tulip Cross ConnectorTo measure and cut the Adjustable Tulip to Tulip Cross Connector, use the Cross Connector Calipers to determine the tulip-to-tulip distance between the screws where the Cross Connector will be placed. To do this, use the spherical-tip (gold) side of the calipers (Fig. 68). Engage the spheres into the hexalobe features of the gold Set Screws (Fig. 69) – the distance may now be read on the proximal caliper scale. Identify the determined distance on the Cross Connector Rod using the length markers and silver stripes (Fig. 70). Use the Rod Cutter to trim the Cross Connector Rod to the required length (Fig. 71). It is critical that the rod is inserted into the cutting portion directionally, in the direction of the arrows (Fig. 71a). As the rod is cut, the end of the rod will be deformed to prevent disassembly.

(Fig. 70)

(Fig. 71)

(Fig. 71a)


26

STEP 15:SUPPLEMENTAL INSTRUMENTATION (CONT.)

Cross Connector Placement (cont.)To place the Adjustable Tulip to Tulip Cross Connector:Engage both of the Adjustable Cross Connector Heads using Spoke Drivers (Cross Connector Driver) by lining up the spokes with the drive features on the Cross Connector and pressing down firmly (Fig. 72).

You may snap both Cross Connector Heads onto the tulips and provisionally tighten by applying a moderate amount of torque (Fig. 73).

Note

For an alternative insertion technique you may hold the second Cross Connector Head with your hand and snap it on the tulip with your thumb.

Note

When properly aligned, the load required to snap on the Adjustable Cross Connector Heads is minimal. If you have to apply excessive load to the heads, reconsider the alignment. When the heads properly snap onto the tulips, the tactile feedback can easily be felt.

(Fig. 72)

(Fig. 72a)

(Fig. 73)

To Final Tighten the Adjustable Cross Connector:Place the Counter-Torque on the adjacent screw on the same side of the construct.

Torque off the Adjustable Cross Connector using the break-off Final Tightening Torque Limiting Handle on one side connected to the Spoke Driver.

Repeat on the contralateral side.

RemovalTulip to Tulip Cross Connectors and Extra Rod Connectors are removed by first loosening the silver lock nuts using the Spoke Driver and then using the Final Tightening Shaft to unthread the gold Set Screws from within Multi Axial Screws and Laminar Hooks. Set Screws need to be backed all the way out of the tulips and then threaded back in lightly. (Threading the Set Screws back in is important because it ensures that they don’t fall out when the Tulip to Tulip Cross Connector Cap is removed.) This causes the Tulip to Tulip Cross Connector Cap to pop up from the tulips and allows them to be removed either by hand or by using the Holding Forceps.



27


Cross Connector Placement (cont.)

2. Rod-to-Rod Static Cross ConnectorFirst, use the Cross Connector Calipers to decide the appropriate Cross Connector size (Fig. 74). To do this, use the scalloped tip (silver) side of the calipers. Measure the rod-to-rod distance between the rods where the Static Cross Connector will be placed. Second, use the Holding Forceps to engage the Cross Connector, and place the Cross Connector over the rods at the desired level. Finally, tighten the Set Screws by engaging the Counter-Torque over the first Cross Connector Set Screw and tighten using Final Tightening Shaft (Black) and Final Tightening Torque Limiting Handle. Repeat for the remaining Set Screw (Fig. 75).

Static Cross Connector BendingThe Static Cross Connector may require additional bending to accommodate anatomical requirements. The small metal pegs protruding from the Rod Bender may be used to bend the Static Cross Connectors in the axial plane (effectively adjusting for rod-to-rod distance and amount of spinal cord clearance) (Fig. 76). To utilize this feature, insert the Static Cross Connector onto the pegs and lightly tighten the Set Screws. The bend may now be introduced by squeezing the handles together or by pulling them apart.

The central knob of the Rod Bender can be used to bend the Static Cross Connectors in the coronal plane. To do this, position the center of the Cross Connector in the groove of the Rod Benders central hub. The bend can now be introduced by squeezing the handles together.

(Fig. 76)

Note

Static Cross Connectors range from 28mm to 38mm and are offered in 2mm increments.

Note

The Static Cross Connector offers a 45° lateralized locking mechanism, which directs the Final Tightening Shaft (Black) away from the spinal cord.

(Fig. 74)

(Fig. 75)


28


Rod-to-Rod ConnectorsTwo size options are available in each of the two styles of Rod-to-Rod Connectors – 3.5 to 3.5mm and 3.5 to 5.5mm. These sizes are available for both the Inline (Fig. 77) and Offset Domino (Fig. 78) Rod-to-Rod Connector, giving four total Rod-to-Rod Connector options.

Insert the 3.5mm VuePoint II OCT Rod into the smaller diameter hole (Fig. 79) and provisionally tighten the Set Screw down onto the rod, using the NV20 Rod-to-Rod Final Tightening Shaft and Universal Handle. Then select the appropriate rod diameter for the opposite end, and again provisionally tighten the Set Screw down onto the rod.

Once both rods are in place, use the NV20 Rod-to-Rod Final Tightening Shaft and Rod-to-Rod Driver Torque Limiting Handle to final tighten the Set Screws. The Rod-to-Rod Driver Torque Limiting Handle will release at 60 in./lbs.

Note

The 3.5 to 5.5mm Offset Domino Rod-to-Rod Connector accommodates various angles between the rods within the sagittal plane (Fig. 79).

(Fig. 77)

(Fig. 78)

(Fig. 79)



29


Extra Rod Connectors/Longitudinal ConnectorsThe Extra Rod Connector connects to Multi Axial Screws and Hooks in the same fashion as the Adjustable Cross Connector caps (Fig. 80).

They allow placement of an additional rod medially or laterally (Fig. 81) from the main construct, or across the construct.

Final tighten in the same fashion as the Adjustable Cross Connector. (See page 25.)

Note

Extra Rod Connectors can be used transversely or diagonally across the construct to act as a robust Cross Connector.

CAUTIONRod-to-Rod Connectors must be used when connecting two separate constructs. Do NOT use VuePoint II Extra Rod Connectors, as the mechanical strength is not adequate for stable fixation of two separate constructs.

(Fig. 80)

(Fig. 81)


30

REMOVALIf it becomes necessary to remove the VuePoint II construct:

1. Remove Cross Connectors and Extra Rod Connectors if necessary. Fixed Cross Connectors are removed by loosening the Set Screws and taking the Cross Connector out using Holding Forceps. Tulip to Tulip Cross Connectors and Extra Rod Connectors are removed by first loosening the silver lock nuts using the Spoke Driver and then using the Final Tightening Shaft (Black) to unthread the gold Set Screws from within Multi Axial Screws and Laminar Hooks. Set Screws need to be backed all the way out of the tulips and then threaded back in lightly. (Threading the Set Screws back in is important because it ensures that they don’t fall out when the Tulip to Tulip Cross Connector Cap is removed.) This causes the Tulip to Tulip Cross Connector Cap to pop up from the tulips and allows them to be removed either by hand or by using the Holding Forceps.

2. Unthread Set Screws from Multi Axial Screws, Laminar Hooks, Keel Plate, or Eyelet Connectors.

3. Remove rods using the Holding Forceps.4. Use Final Tightening Shaft (Black) to remove Multi Axial

Screws and Occipital Bone Screws, as well as Keel Plate or Eyelet Connectors. Laminar Hooks may either be removed using the Holding Forceps or re-engaged with a Threaded Driver.

5. It may be necessary to use the Alignment Tool to reposition Multi Axial Screw tulips for driver re-engagement. If the multi axial motion remains locked after Set Screw removal in Step 2, the Alignment Tool or Counter-Torque may be used to unthread tulip screws.



V U E P O I N T ® I I O C C I P I TA L T E C H N I Q U E

32

Drill Bit

VUEPOINT II OCCIPITAL INSTRUMENTATION OPTIONSThe VuePoint II OCT system offers both standard (straight) and angled occipital instrumentation. This array of instrumentation options allows surgeons to more easily address various surgical scenarios.

Standard instrumentation should be used in the majority of cases when direct access and trajectories are not overly challenging, and there are not anatomical obstacles that make straight instrumentation problematic.

Angled instrumentation should be used when necessary to help navigate cases with difficult occipital angles and challenging thoracic anatomy. Angled instrumentation will help avoid obstructions that may make straight instrumentation strenuous to achieve desired results.

Both the Straight and Angled Occipital Drills and Taps should be used through the Drill/Tap Guide to ensure proper depth.

The Long Angled Occipital Driver should be used through the Drill/Tap Guide to provide stability.

Standard Instrumentation

Counter-Torque

Angled Counter-Torque Driver

Angled Driver

Angled Drill Bit

Angled Tap

Allen Wrench

Angled Instrumentation

Screw Driver Shaft

Tap



33

STEP 1:OCCIPITAL KEEL PLATE PLACEMENT

Two fixation options are available to address the occiput:

1. The Occipital Keel Plate

2. Eyelet Connectors

Occipital Keel PlateThe Occipital Keel Plate offers a maximum of five screw placement sites, three in the midline and two lateral. The unique blue/silver bi-colored plate design allows you to visualize proper orientation of the plate: the silver side of the plate should face superior (Fig. 82), which orients the light blue locking Set Screws superiorly. The Keel Plate arms move medial-lateral from 37mm to 47mm and swing cranial-caudal (Figs. 83, 84).

After burring down any bony protuberances (while still maintaining the integrity of the cortical bone), if necessary, the plate can be bent to best match the contour of the patient’s occiput (Fig. 85).

To bend the Keel Plate, it must first be fully compressed to its shortest width and the blue Set Screws finger-tightened. The Keel Plate Bender must then be set to either the concave or convex bend by pulling on the anvil portion and turning it 180.° The plate may then be loaded into the bender with blue Set Screws and the silver side of the plate pointing away from the instrument (Figs. 86, 87).

(Fig. 82) (Fig. 83)

(Fig. 84)

(Fig. 85)

(Fig. 86) (Fig. 87)

CAUTIONCare must be exercised not to over bend the Occipital Keel Plate. Do not unbend the plate once the plate is bent, as this may compromise the mechanical strength, and/or cause interference with the Occipital Drill/Tap Guide.


34

STEP 1:OCCIPITAL KEEL PLATE PLACEMENT (CONT.)

Occipital Keel Plate FixationCompress the connector arms fully, and lightly finger-tighten the blue Set Screws (Fig. 88). Engage the Occipital Keel Plate with the Keel Plate Holder through the lateral holes of the plate (Fig. 89).

(Fig. 88)

(Fig. 89)



35

STEP 2:OCCIPITAL SCREW PLACEMENT

Select the desired drill depth by pulling the proximal part of the Occipital Drill/Tap Guide backward and toward the handle (Fig. 90). Turn the knurled end of the instrument to the desired depth, noted by the small metal slide which sits in the numbered slot. Insert the Drill/Tap Guide through the aperture of the plate (Fig. 91). Place Drill Bit, attached to power drill, through the Drill/Tap Guide. Drill the three midline holes to desired depth (Fig. 92).

Occipital Bone Screws require hand-tapping to depth (Fig. 93). Attach the Straight Occipital Tap to the Occipital Fat Handle and place through the Drill/Tap Guide. When the depth stop meets the top of the Drill/Tap Guide, stop rotating the tap. Failure to do so may cause threads to strip.

(Fig. 92)

(Fig. 92a)

(Fig. 91)

(Fig. 93)

(Fig. 93a)

CAUTIONTo prevent stripping of the tap threads, do not attach the tap to power. Always hand-tap to depth.

Note

Another option for occipital placement is to place the plate on the occiput and mark the center hole, remove the plate, and drill the hole using the Drill/Tap Guide; then tap the screw hole. After this hole has been created, place the plate back on the occiput and put in your first screw at this site. The benefit of this technique is that it does not require assistance holding the plate holder in place. (Whether you drill through the plate or directly on bone, the depth of the hole in bone will always correspond to the depth setting on the guide. Depth is measured from the bottom of the distal teeth of the guide to the tip of the drill.)

(Fig. 90)


36

STEP 2:OCCIPITAL SCREW PLACEMENT (CONT.)

Select proper screw length (6-14mm, in 2mm increments) and diameter (blue 4.5mm primary or grey 5.0mm rescue) (Figs. 94, 95). Pick up screw with the Tapered Hex Driver, attached to the Universal Handle. Place the Occipital Bone Screws through the midline holes. Repeat for lateral screw placements while the connector arms are fully compressed. The Occipital Bone Screws can be placed with up to -20 o of angular variability (Fig. 96).

After all desired Bone Screws have been placed, you may loosen the blue Set Screws about a quarter-turn (Fig. 97) to release the mobility of the connector arms and allow for easy connection to the rods (Fig. 98). This step may obscure access to the lateral screws, so they should be fully tightened down to the occiput before adjusting the connector arms to connect the rods.

CAUTIONLateral screws must be placed through the Occipital Keel Plate prior to opening/expanding the plate arms. Once the plate arms are expanded and locked in place, the lateral screw holes are no longer accessible.

CAUTIONAvoid extreme trajectories for screw placement on the VuePoint II Occipital Keel Plate, specifically where the Drill/Tap Guide is pushed on the plate. This may cause screws to not bottom out and strip the bone; it may also hinder translation of connector arms.

Note

Occipital Bone Screws are offered in 4.5mm and 5.0mm diameters, ranging from 6mm to 14mm lengths. The 4.5mm screws are recommended for primary screw placement. The 5.0mm screws should be used only as a rescue screw option.

(Fig. 94) (Fig. 95)

(Fig. 97)

(Fig. 98)

(Fig. 96)



37

(Fig. 101)

(Fig. 101a)

(Fig. 100)

(Fig. 102)

(Fig. 102a)

CAUTIONTo prevent stripping of the tap threads, do not attach the tap to power. Always hand-tap to depth.

Note

Another option for occipital placement is to place the plate on the occiput and mark the center hole, remove the plate, and drill the hole using the Drill/Tap Guide; then tap the screw hole. After this hole has been created, place the plate back on the occiput and put in your first screw at this site. The benefit of this technique is that it does not require assistance holding the plate holder in place. (Whether you drill through the plate or directly on bone, the depth of the hole in bone will always correspond to the depth setting on the guide. Depth is measured from the bottom of the distal teeth of the guide to the tip of the drill.)

(Fig. 99)

ALTERNATE METHOD

ANGLED INSTRUMENTATIONOCCIPITAL SCREW PLACEMENT

Alternatively, you may use angled instrumentation to complete Step 2.

Select the desired drill depth by pulling the proximal part of the Occipital Drill/Tap Guide backward and toward the handle (Fig. 99). Turn the knurled end of the instrument to the desired depth, noted by the small metal slide which sits in the numbered slot. Insert the Drill/Tap Guide through the aperture of the plate (Fig. 100). Place Angled Occipital Drill Bit, attached to power drill, through the Drill/Tap Guide. Drill the three midline holes to desired depth (Fig. 101).

Occipital Bone Screws require hand-tapping to depth (Fig. 102). Attach the Angled Occipital Tap to the Occipital Fat Handle and place through the Drill/Tap Guide. When the depth stop meets the top of the Drill/Tap Guide, stop rotating the Angled Occipital Tap. Failure to do so may cause threads to strip.

V U E P O I N T ® I I O C C I P I TA L T E C H N I Q U EV U E P O I N T ® I I O C C I P I TA L T E C H N I Q U E

38

CAUTIONLateral screws must be placed through the Occipital Keel Plate prior to opening/expanding the plate arms. Once the plate arms are expanded and locked in place, the lateral screw holes are no longer accessible.

CAUTIONAvoid extreme trajectories for screw placement on the VuePoint II Occipital Keel Plate, specifically where the Drill/Tap Guide is pushed on the plate. This may cause screws to not bottom out and strip the bone; it may also hinder translation of connector arms.

Note

Occipital Bone Screws are offered in 4.5mm and 5.0mm diameters, ranging from 6mm to 14mm lengths. The 4.5mm screws are recommended for primary screw placement. The 5.0mm screws should be used only as a rescue screw option.

(Fig. 103) (Fig. 104)

(Fig. 106)

(Fig. 105)

ALTERNATE METHOD

ANGLED INSTRUMENTATIONOCCIPITAL SCREW PLACEMENT (CONT.)

Select proper screw length (6-14mm, in 2mm increments) and diameter (blue 4.5mm primary or grey 5.0mm rescue) (Figs. 103, 104). Pick up screw with the Angled Occipital Driver (Long or Short), attached to the Universal Handle. The Long Angled Occipital Driver should be used through the Drill/Tap Guide. Place the Occipital Bone Screws through the midline holes (Fig. 105). Repeat for lateral screw placements while the connector arms are fully compressed. The Occipital Bone Screws can be placed with up to -20 o of angular variability (Fig. 106).

After all desired Bone Screws have been placed, you may loosen the blue Set Screws about a quarter-turn (Reference page 36, Fig. 97) to release the mobility of the connector arms and allow for easy connection to the rods (Reference page 36, Fig. 98). This step may obscure access to the lateral screws, so they should be fully tightened down to the occiput before adjusting the connector arms to connect the rods.

V U E P O I N T ® I I O C C I P I TA L T E C H N I Q U EV U E P O I N T ® I I O C C I P I TA L T E C H N I Q U E


39

(Fig. 108)

STEP 3:CONNECTOR ARM TIGHTENING

To lock down the arms of the plate, use the Final Tightening Shaft (Black) and Final Tightening Torque Limiting Handle to tighten the light blue Set Screws and lock the plate into desired configuration (Fig. 107). A Counter-Torque is not required. If needed, it is possible to Counter-Torque off of the Keel Plate tulip connectors.

STEP 4:LOCKING DOWN THE ROD

Once the rod is bent, use the Set Screw Repeater or Tapered Hex Driver to place Set Screws over the rod and tighten them in place (Fig. 108). Attach the black-colored Final Tightening Shaft (Black) to the Final Tightening Torque Limiting Handle, and insert through the Counter-Torque to final tighten (Fig. 109). A tactile and audible “click” indicates the Set Screw is locked at the recommended 26 in./lb. (3 N-m) of torque.

Note

A Hinged Rod or Precurved Rod can be provisionally tightened down when all Occipital Bone Screws, Multi Axial Screws, and Laminar Hooks are in place. (Fig. 107)

(Fig. 109)


40(Fig. 111)

(Fig. 110)

ALTERNATE METHOD

ANGLED INSTRUMENTATIONLOCKING DOWN THE ROD

Once the rod is bent, attach the Angled Occipital Counter-Torque Driver to the Final Tightening Torque Limiting Handle (Fig. 110). Engage a Set Screw with the driver portion of the Angled Occipital Counter-Torque Driver. To do this, push the driver forward and out of the Counter-Torque. Engage the occipital tulip with the Angled Occipital Counter-Torque Driver, and rotate the Final Tightening Torque Limiting Handle to deliver the Set Screw (Fig. 111). Once the Set Screw is fully in place, ensure that the Angled Counter-Torque laser mark on the driver handle is aligned with one of the laser marks on the driver shaft (Fig. 111a). Turn the Final Tightening Torque Limiting Handle until you get a tactile and audible “click,” confirming it is locked at the recommended 26 in./lb. (3 N-m) of torque.

Note

If the Set Screw is final tightened and laser marks are not in line, release Set Screw from driver shaft and re-engage with the Angled Counter-Torque so the laser marks are in line and repeat Set Screw tightening.



(Fig. 111a)

41

STEP 5:HINGED ROD

The Hinged Rod may be used in occipital cases for ease of placement and may allow the surgeon to avoid weakening the titanium rod with extreme bends that are often required to fixate the skull in the desired position (Fig. 112). In the unlocked state, the Hinged Rod can be adjusted to the desired angle and then rigidly locked. The Hinged Rod is locked by engaging the Counter-Torque over the hinge and tightening the blue Set Screw to 26 in./lb. (3 N-m), using the Final Tightening Shaft (Black) and Final Tightening Torque Limiting Handle (Fig. 113).

(Fig. 113)

(Fig. 112)

Note

The Hinged Rod Set Screws need to be provisionally tightened before final tightening of the Multi Axial Screws, Laminar Hooks, and Occipital Keel Plate.


42

STEP 6:OCCIPITAL EYELET CONNECTORS

Eyelet Connector FixationAlternatively, Occipital Eyelet Connectors can be utilized for occipital fixation (Fig. 114). Eyelet Connectors allow for increased flexibility of Bone Screw placement because they are placed independently of each other (Fig. 115).

After bending the rod to match the occipital anatomy, preload the Eyelet Connectors to the rod and provisionally tighten. Connect the desired number of Eyelets for each rod (Fig. 116).

Drill, tap, and place Occipital Bone Screws as prescribed earlier in the Occipital Keel Plate step (page 35). Place the Counter-Torque over the Eyelet Connector and use the Final Tightening Shaft (Black) and Final Tightening Torque Limiting Handle assembly to final tighten.

(Fig. 114)

(Fig. 115)

(Fig. 116)



43

REMOVALIf it becomes necessary to remove the VuePoint II construct:

1. Remove Cross Connectors and Extra Rod Connectors if necessary. Fixed Cross Connectors are removed by loosening the Set Screws and taking the Cross Connector out using Holding Forceps. Tulip to Tulip Cross Connectors and Extra Rod Connectors are removed by first loosening the silver lock nuts using the Spoke Driver and then using the Final Tightening Shaft (Black) to unthread the gold Set Screws from within Multi Axial Screws and Laminar Hooks. Set Screws need to be backed all the way out of the tulips and then threaded back in lightly. (Threading the Set Screws back in is important because it ensures that they don’t fall out when the Tulip to Tulip Cross Connector Cap is removed.) This causes the Tulip to Tulip Cross Connector Cap to pop up from the tulips and allows them to be removed either by hand or by using the Holding Forceps.

2. Unthread Set Screws from Multi Axial Screws, Laminar Hooks, Occipital Keel Plate, or Eyelet Connectors.

3. Remove rods using the Holding Forceps.4. Use Final Tightening Shaft (Black) to remove Multi Axial

Screws and Occipital Bone Screws, as well as Occipital Keel Plate or Eyelet Connectors. Laminar Hooks may either be removed using the Holding Forceps or re-engaged with a Threaded Driver.

5. It may be necessary to use the Alignment Tool to reposition Multi Axial Screw tulips for driver re-engagement. If the multi axial motion remains locked after Set Screw removal in Step 2, the Alignment Tool or Counter-Torque may be used to unthread tulip screws.


N O T E S


45

PA G E H E A D I N G

V U E P O I N T ® I I S Y S T E M

46

V U E P O I N T I I T R AY 1 ( V U E 2 T R AY 1)

A W L ( 8 9 7 7 0 0 5 )

D E P T H G A U G E ( 8 9 7 7 0 2 0 )

B A L L T I P P R O B E ( 8 9 7 7 0 2 5 )

T A P S H A F T , 3 . 5 m m ( 3 . 0 m m ) ( 8 9 7 7 0 3 5 )

T A P S H A F T , 4 . 0 m m ( 3 . 5 m m ) ( 8 9 7 7 0 4 0 )

2 . 4 m m D R I L L B I T ( 8 9 7 7 0 10 )



47

G E A R S H I F T P R O B E – S T R A I G H T ( 8 9 7 7 16 5 )

G E A R S H I F T P R O B E – C U R V E D ( 8 9 7 7 17 0 )

D R I L L G U I D E , 10 - 4 0 m m ( 8 9 7 7 0 15 )

O C C I P I T A L F A T H A N D L E ( 8 9 7 7 12 5 )U N I V E R S A L H A N D L E ( 8 9 7 7 0 4 5 )


48

A D J U S T A B L E T A P G U I D E , 10 -2 4 m m ( 8 9 7 7 0 3 0 )

V U E P O I N T I I T H R E A D E D D R I V E R ( 8 9 7 7 0 5 2 )

S C R E W D R I V E R S H A F T ( S T A B - N - G O ) ( 8 9 7 7 0 5 5 )

S C R E W D R I V E R S H A F T ( T A P E R E D D R I V E R ) ( 8 9 7 7 0 6 0 )

A L I G N M E N T T O O L ( 8 9 7 7 0 7 5 )

F I N A L T I G H T E N I N G S H A F T ( B L A C K ) ( 8 9 7 7 0 9 5 )

12 0 m m R O D T E M P L A T E ( 8 9 7 0 12 0 )

2 4 0 m m R O D T E M P L A T E ( 8 9 7 0 2 4 0 )



49

C O U N T E R-T O R Q U E ( 8 9 7 7 10 0 ) F I N A L T I G H T E N I N G T O R Q U E L I M I T I N G H A N D L E ( 8 9 7 7 0 9 0 )

S E T S C R E W R E P E A T E R ( 8 9 7 7 0 6 5 )

R O D C U T T E R ( 8 9 7 7 10 5 )R O D B E N D E R ( 8 9 7 7 110 )


50

C O M P R E S S O R ( 8 9 7 7 15 5 )

I N - S I T U R O D B E N D E R ( R I G H T ) / T U B E B E N D E R ( B E N D I N G I R O N , R ) ( 8 9 7 7 13 0 )

D I S T R A C T O R ( 8 9 7 7 16 0 )

I N - S I T U R O D B E N D E R ( L E F T ) / T U B E B E N D E R ( B E N D I N G I R O N , L ) ( 8 9 7 7 13 5 )

V U E P O I N T I I T R AY 2 ( V U E 2 T R AY 2 )

R E D U C T I O N T O W E R S ( 8 9 7 7 0 8 0 )



51

R O D -T O - R O D D R I V E R S H A F T ( N V 2 0 ) ( 8 9 7 7 18 0 )

R O C K E R ( P I T C H F O R K ) ( 8 9 7 7 19 0 )

R O D -T O - R O D D R I V E R T O R Q U E L I M I T I N G H A N D L E ( 8 9 7 7 18 5 )

C R O S S C O N N E C T O R C A L I P E R S ( 8 9 7 7 15 0 )

R O D G R I P P E R ( 8 9 7 7 12 0 )

R O D H O L D E R / H O O K H O L D E R / R O D -T O - R O D C O N N E C T O R H O L D E R ( H O L D I N G F O R C E P S ) ( 8 9 7 7 115 )

S P O K E D R I V E R ( 8 9 7 7 1 4 5 )


52

V U E P O I N T I I I N S T R U M E N T S

V U E P O I N T I I O C C I P I T A L T R AY ( V U E 2 T R AY O C C )

O C C I P I T A L D R I L L / T A P G U I D E ( 8 9 7 7 3 5 0 )

S T R A I G H T O C C I P I T A L T A P, 4 . 5 m m ( 8 9 7 7 3 4 5 )

S T R A I G H T O C C I P I T A L D R I L L B I T S H A F T , 3 . 3 5 m m ( 8 9 7 7 3 3 5 )

M I D L I N E K E E L P L A T E B E N D E R ( 8 9 7 7 3 6 0 ) K E E L P L A T E H O L D E R ( 8 9 7 7 3 5 5 )



53

V U E P O I N T I I A N G L E D I N S T R U M E N T S ( N o t s t a n d a r d i n oc c i p i t a l t r a y ; o r d e r s e p a r a t e l y )

A N G L E D O C C I P I T A L C O U N T E R-T O R Q U E D R I V E R ( 8 9 7 7 3 7 0 )

A N G L E D O C C I P I T A L D R I V E R - L O N G ( 8 9 7 7 3 7 5 )

A N G L E D O C C I P I T A L D R I L L B I T ( 8 9 7 7 3 8 0 )

A L L E N W R E N C H F O R O C C I P I T A L ( 8 9 7 7 3 9 0 )

A N G L E D O C C I P I T A L D R I V E R - S H O R T ( 8 9 7 7 3 7 7 )

A N G L E D O C C I P I T A L T A P ( 8 9 7 7 3 8 5 )


54

C ATA L O G


DESCRIPTION CATALOG #

4.5mm MULTI AXIAL SCREWS4.5 x 10mm Multi Axial Screw, L 8975710

4.5 x 12mm Multi Axial Screw, L 8975712
















3.5mm FAVORED ANGLE SCREWS3.5 x 10mm Favored Angle Screw 8975510

3.5 x 12mm Favored Angle Screw 8975512










































M U LT I A X I A L S C R E W S M U LT I A X I A L S C R E W S ( C O N T. )

FAV O R E D A N G L E S C R E W S

55


4.0mm FAVORED ANGLE SCREWS4.0 x 10mm Favored Angle Screw 8975610

















3.5mm PARTIALLY THREADED SCREWS (10 SMOOTH)3.5 x 24mm Partially Threaded Screw 8975824

3.5 x 26mm Partially Threaded Screw 8975826







11mm Offset Connector (open) 8976011

25mm Offset Connector (open) 8976025

Acute-Angle Offset Connector (45°) 8976030


Set Screw - Occipital Tulip Screw & Laminar Hook 8970000

60mm Rod, 3.5mm 8976106

80mm Precontoured Rod 8976180

120mm Rod, 3.5mm 8976112

240mm Rod, 3.5mm 8976124

3.5mm to 5.5mm Transition Rod 8976355


6.0mm Laminar Hook 8976006

8.0mm Laminar Hook 8976008


Adjustable Cross Connector (Tulip to Tulip) 8972360

Static 28mm Cross Connector 8976128







3.5mm to 3.5mm Inline Rod-to-Rod Connector 8976035

3.5mm to 5.5mm Inline Rod-to-Rod Connector 8976055


3.5mm to 3.5mm Domino Offset Rod-to-Rod Connector (open) 8976435

3.5mm to 5.5mm Domino Offset Rod-to-Rod Connector (open) 8976455


Extra Rod Connector 8976165

FAV O R E D A N G L E S C R E W S ( C O N T. )

PA R T I A L LY T H R E A D E D S C R E W S

O F F S E T L AT E R A L C O N N E C T O R S

S E T S C R E W S A N D R O D S

H O O K S

C R O S S C O N N E C T O R S

I N L I N E R O D -T O - R O D C O N N E C T O R S

O F F S E T R O D -T O - R O D C O N N E C T O R S

E X T R A R O D C O N N E C T O R

C ATA L O G

56


Set Screw – Offset & Occipital Connectors & Eyelets 8977760

Set Screw – Rod-to-Rod Connectors 8977765

Set Screw – Static Cross Connector 8977770


2.4mm Drill Bit 8977010

120mm Rod Template 8970120

240mm Rod Template 8970240


Awl 8977005

Ball Tip Probe 8977025

Depth Gauge 8977020

Tap Shaft, 3.5mm (3.0mm) 8977035

Tap Shaft, 4.0mm (3.5mm) 8977040

Gearshift Probe – Straight 8977165

Gearshift Probe – Curved 8977170

Universal Handle 8977045

Occipital Fat Handle 8977125

Drill Guide, 10-40mm 8977015

Adjustable Tap Guide, 10-24mm 8977030

Screw Driver Shaft (Stab-n-Go) 8977055

Screw Driver Shaft (Tapered Driver) 8977060

Threaded Driver – VuePoint® II 8977052

Set Screw Repeater 8977065

Alignment Tool 8977075

Rod Holder/Hook Holder/ Rod-to-Rod Connector Holder (Holding Forceps) 8977115

Final Tightening Shaft (Black) 8977095

Counter-Torque 8977100

Final Tightening Torque Limiting Handle 8977090

Rod Cutter 8977105

Rod Bender 8977110

Rod Gripper 8977120

Reduction Towers 8977080

Rocker (Pitch Fork) 8977190

Compressor 8977155

Distractor 8977160


Cross Connector Calipers 8977150

Spoke Driver 8977145

In-Situ Rod Bender (Right)/Tube Bender (Bending Iron, R) 8977130

In-Situ Rod Bender (Left)/Tube Bender (Bending Iron, L) 8977135

Rod-to-Rod Driver Shaft (NV20) 8977180

Rod-to-Rod Driver Torque Limiting Handle 8977185


Adjustable Keel Plate 8975000

Low-Profile Eyelets 8976305

4.5 x 6mm Cortical Occipital Screw, L 8976406










Hinged Rod 8976300

240mm Precurved Rod (45°) 8976240


Straight Occipital Drill Bit Shaft, 3.35mm 8977335

Straight Occipital Tap, 4.5mm 8977345

Occipital Drill/Tap Guide 8977350

Midline Keel Plate Bender 8977360

Keel Plate Holder 8977355


Angled Occipital Counter-Torque Driver 8977370

Angled Occipital Driver – Long 8977375

Angled Occipital Driver – Short 8977377

Angled Occipital Drill Bit 8977380

Angled Occipital Tap 8977385

Allen Wrench for Occipital 8977390

M I S C E L L A N E O U S S E T S C R E W S

D I S P O S A B L E I N S T R U M E N T S

S TA N D A R D I N S T R U M E N T S

S TA N D A R D I N S T R U M E N T S ( C O N T. )

O C C I P I TA L I M P L A N T S

O C C I P I TA L I N S T R U M E N T S

O C C I P I TA L A N G L E D I N S T R U M E N T S(Not standard in occipital tray; order separately)

C ATA L O G


57


VP II Base, Case 1 8970002

VP II Bottom, Case 1 8970003

VP II Middle, Case 1 8970004

VP II Top, Case 1 8970005

VP II Lid, Multi Axial Caddy, Case 1 8970006

VP II Multi Axial Caddy, Case 1 8970007

VP II Lid, Favored Caddy, Case 1 8970008

VP II Favored Caddy, Case 1 8970009

VP II Lid, 4.5 MA Caddy, Case 1 8970010

VP II 4.5 MA Caddy, Case 1 8970011

VP II Lid, Partial Caddy, Case 1 8970012

VP II Partial Caddy, Case 1 8970013

VP II Lid, Set Screw Caddy, Case 1 8970014

VP II, Set Screw Caddy, Case 1 8970015

VP II Base, Case 2 8970020

VP II Bottom, Case 2 8970021

VP II Middle, Case 2 8970022

VP II Top, Case 2 8970023

VP II Lid, Connector Caddy, Case 2 8970024

VP II Connector Caddy, Case 2 8970025

VP II Lid, Misc. Set Screw Caddy, Case 2 8970026

VP II Misc. Set Screw Caddy, Case 2 8970027

VP II Base, Occipital Tray 8970030

VP II Lid, Occipital Implant Caddy 8970032

VP II Occipital Implant Caddy 8970033


MEP/EMG Electrodes (Needle) 8050215

MEP/EMG Electrodes (Surface) 8020215

SSEP Electrodes 8050315

Ball Tip Probe 2012021

C A S E S

N V M 5® D I S P O S A B L E S


COBALT CHROME RODSCoCr Rod, 240mm 7908240

Prebent CoCr Rod 7908300

Transition CoCr Rod, 3.5mm-5.5 mm 7908355

GRIT-BLASTED CROSS CONNECTORS26mm Grit-Blasted Cross Connector 7908026

28mm Grit-Blasted Cross Connector 7908028












Grit-Blasted Cross Connector Set Screw 7908052

VUEPOINT® OCT INSTRUCTIONS FOR USEVuePoint OCT Instructions for Use 9400215

C O B A LT C H R O M E ( S E PA R AT E T R AY )

(Must be ordered separately)

C ATA L O G

58

DESCRIPTIONThe NuVasive® VuePoint® OCT System consists of a series of polyaxial screws, collets, rods, offset connectors, set screws, and cross connectors manufactured from Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3, and CoCr per ASTM F90 or ASTM F1537.

INDICATIONS FOR USE The VuePoint OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

2. Degenerative spondylolisthesis with objective evidence of neurologic impairment3. Fracture/Dislocation4. Spinal Stenosis5. Atlantoaxial fracture with instability6. Occipitocervical dislocation7. Spinal tumor and/or8. Revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx® Spinal System via the rod to rod connectors or transition rods.

CONTRAINDICATIONSContraindications include but are not limited to:

1. Infection, local to the operative site.2. Signs of local inflammation.3. Patients with known sensitivity to the materials implanted.4. Patients who are unwilling to restrict activities or follow medical advice.5. Patients with inadequate bone stock or quality.6. Patients with physical or medical conditions that would prohibit beneficial surgical outcome.7. Use with components of other systems.8. Reuse or multiple uses.

POTENTIAL ADVERSE EVENTS AND COMPLICATIONSAs with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity. Rarely, some complications may be fatal.

Potential risks identified with the use of this system, which may require additional surgery, include:

• Bending, fracture or loosening of implant component(s)• Loss of fixation• Nonunion or delayed union• Fracture of the vertebra• Neurological, vascular or visceral injury• Metal sensitivity or allergic reaction to a foreign body• Infection• Decrease in bone density due to stress shielding• Pain, discomfort or abnormal sensations due to the presence of the device• Nerve damage due to surgical trauma• Bursitis• Dural leak• Paralysis • Death

WARNINGS, CAUTIONS AND PRECAUTIONSThe subject device is intended for use only as indicated.

The implantation of the VuePoint OCT System should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

Correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size of the implant. The VuePoint OCT System can also be linked to Ø3.5 mm – Ø6.25 mm rods of posterior pedicle screw and rod systems via the rod to rod connectors or transition rods. While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Metallic and internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.

Caution must be taken due to potential patient sensitivity to materials. Do not implant in patients with known or suspected sensitivity to the aforementioned materials.

These devices can break when subjected to the increased load associated with delayed union or non-union. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient’s activity level will dictate the longevity of the implant.

Corrosion of the implant can occur. Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion. Placing dissimilar metals in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants. Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other.

Care should be taken to insure that all components are ideally fixated prior to closure.

PATIENT EDUCATION: Preoperative instructions to the patient are essential. The patient should be made aware of the limitations of the implant and potential risks of the surgery. The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components. The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.

SINGLE USE: Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents. Resterilization may result in damage or decreased performance.

MAGNETIC RESONANCE (MR) SAFETY: The VuePoint OCT System has not been evaluated for safety and compatibility in the MR environment. The VuePoint OCT System has not been tested for heating or migration in the MR environment.

COMPATIBILITY: Do not use VuePoint OCT System with components of other systems. Unless stated otherwise, NuVasive devices are not to be combined with the components of another system.

All implants should be used only with the appropriately designated instrument (Reference Surgical Technique).

Instruments and implants are not interchangeable between systems.

Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.

Based on the fatigue testing results, when using the NuVasive VuePoint OCT System, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system.

To maintain the mechanical integrity of the Cross Connector, once the Connector is bent in one direction, further bending only in that same direction should be attempted. Unbending of the Connector may cause mechanical compromise.

I N S T R U C T I O N S F O R U S E


59

To maintain the mechanical integrity of the plate, once the plate is bent in one direction with either tool, further bending only in that same direction should be attempted. Unbending of the plate may cause mechanical compromise.

To prevent stripping, stop tapping when the tap bottoms out on the Tap Guide.

It is possible to pull out the screw if too much force is applied with the Persuader.

Rod-to-Rod Connectors must be used when connecting two separate constructs. Do NOT use VuePoint II Extra Rod Connectors as the mechanical strength is not adequate for stable fixation of two separate constructs.

Care must be exercised not to over bend the Occipital Keel Plate. Do not unbend the plate once the plate is bent, as this may compromise the mechanical strength.

Care must be exercised not to over bend the Occipital Keel Plate as it may cause interference with the Occipital Drill/Tap Guide.

To prevent stripping of the tap threads, do not attach the tap to power. Always hand-tap to depth.

Lateral screws must be placed through the Occipital Plate prior to opening/expanding the plate arms. Once the plate arms are expanded and locked in place, the lateral screw holes are no longer accessible.

Avoid extreme trajectories for screw placement on the VuePoint II Occipital Plate specifically where the Drill/Tap Guide is pushed on the plate. This may cause screws to not bottom out and strip the bone; it may also hinder translation of connector arms.

Exercise caution when using the Set Screw Repeater, as pulling up on the instrument may result in screw pullout or extreme forces on the spine.

PREOPERATIVE WARNINGS1. Only patients that meet the criteria described in the indications should be selected.2. Patient condition and/or predispositions such as those addressed in the aforementioned

contraindications should be avoided. 3. Care should be used in the handling and storage of the implants. The implants should not be

scratched or damaged. Implants and instruments should be protected during storage and from corrosive environments.

4. All non-sterile parts should be cleaned and sterilized before use. 5. Devices should be inspected for damage prior to implantation. 6. Care should be used during surgical procedures to prevent damage to the device(s) and injury

to the patient.

POST-OPERATIVE WARNINGSDuring the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.

Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications. To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.

I N S T R U C T I O N S F O R U S E

N O T E S


9501044 Ewww.nuvasive.com©2015. NuVasive, Inc. All rights reserved. , NuVasive, Speed of Innovation, CoRoent, NVM5, Osteocel, SpheRx, and VuePoint are

registered trademarks of NuVasive, Inc. Small Interlock is a trademark of NuVasive, Inc.

To order, please contact your NuVasive® Sales Consultant or Customer Service Representative today at:NuVasive, Inc. 7475 Lusk Blvd., San Diego, CA 92121 USA • phone: 800-475-9131 fax: 800-475-9134

NuVasive UK Ltd. Suite B, Ground Floor, Caspian House, The Waterfront, Elstree, Herts WD6 3BS UKphone: +44 (0) 208-238-7850 fax: +44 (0) 207-998-7818

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