cd horizon surg tech revision - mt ortho

CD Horizon®

Spinal System Surgical Technique

as described by:

Samuel J. Laufer, M.D.

J. AndrewBowe, M.D.

Robert WoodJohnson UniversityHospital

New Brunswick,New Jersey

contents

Introduction ............................................................................................... 2

Design Criteria .......................................................................................... 3

Implants ....................................................................................................... 4

Instruments................................................................................................. 5

Surgical Technique Steps

Patient Position 8

Incision and Exposure 9

Hook Placement 10

Pedicle Hook 10

Supralaminar Position 11

Infralaminar Position 11

Transverse Process Position 12

Rod Contouring 13

Rod Insertion 14

Force Application/Rod Rotation .............................................. 22

Bone Grafting and CROSSLINK® Plating ............................... 23

Final Tightening and Closure..................................................... 25

S U R G I C A L T E C H N I Q U E

CD HORIZON®

SPINAL SYSTEM

Introduction

The CD HORIZON® Spinal System represents a furtherdevelopment of the Cotrel-Dubousset Instrumentation designed by Dr. Yves Cotrel and based on the three-dimensional surgicalcorrection techniques developed by Professor Jean Dubousset.Additionally, the CD HORIZON Spinal System expands on earlierconcepts by providing the surgeon with various technique options,including rod rotation, translation, segmental correction, in-siturod contouring or combinations of these methods.

The basic objective of the original Cotrel-Dubousset system alsoapplies to the CD HORIZON Spinal System. That is, to restore as completely as possible the balance of the spine in all threeanatomical planes. Therefore, simultaneous visualization of thedeformity in the three planes is essential for operative correction.Comprehensive preoperative radiographic studies should be utilizedto determine the “strategic vertebrae” in order to mobilize themand then, by segmental actions obtain deformity correctioncompatible with three-dimensional spinal balance.

It is beyond the scope of this presentation to address the basicprinciples of three-dimensional instrumentation and correction.Rather, this manual is presented only as a technique guide forutilization of the CD HORIZON Spinal System implants andinstruments. It is recommended that the inexperienced surgeonattend organized scientific meetings and learn from other surgeonswith greater experience the concepts, principles, and techniques of three-dimensional surgical correction of the spine.

NOTE: Illustrations have been simplified for clarity. The case presented is forillustrative purposes only.


CD HORIZON®

SPINAL SYSTEM

2

Design criteria

The CD HORIZON® Spinal System design criteria were based

on a decade’s worth of worldwide surgical experience with Cotrel-

Dubousset Instrumentation. The characteristics of the system are

numerous and several are listed below:

• Efficient instruments

• Top loading, top tightening implants

• Low profile, anatomically designed implants

• Adaptable to various surgical techniques

• Allows for decreased inventory requirements

• Revisability

The range of CD HORIZON Spinal System implants

and instruments are on the following pages.


CD HORIZON®

SPINAL SYSTEM

3

LOW PROFILECROSSLINK®

PLATES

Implants

CD HORIZON® SPINAL SYSTEM IMPLANTS


CD HORIZON®

SPINAL SYSTEM

4

PedicleHook

Wide BladeSmall Groove

Hook

Wide BladeHook

Narrow BladeHook

Angled BladeHook

Left OffsetHook

Right OffsetHook Narrow Blade

RampedHook

StandardBlade Ramped

HookLeft Angled

Hook

Right AngledHook

Extended BodyHook

LargePedicle Hook

Break-off SetScrew

DominoConnector

AxialConnector

CROSSLINKOffset Plate

CROSSLINKPlate

CROSSLINKMulti-Span® Plate

LargeGroove Hook

Narrow Blade,Small Groove

Hook

Extended Body,Large Groove

Hook

Hex EndRod

6.5mm x 40mmBone Screw



Instruments

CD HORIZON® SPINAL SYSTEM INSTRUMENTS


CD HORIZON®

SPINAL SYSTEM

5

Final PlugDriver

Provisional PlugDriver

T20 / T25Shaft

Modular Handle forT20 / T25

Shaft

In-situBenders

HookPusher

RodPusher

FrenchBender

Dual PurposeHook Pusher

Dual PurposeImplant Holder

CounterTorque

instruments (continued)

CD HORIZON® SPINAL SYSTEM INSTRUMENTS


CD HORIZON®

SPINAL SYSTEM

6

RodHolder

Power Grip

LateralImplant Holder

CurvedImplant Holder

StraightImplant Holder

CurvedCompressor

CurvedSpreader

TransverseProcessElevator

PedicleFinder

LaminarElevator


CD HORIZON®

SPINAL SYSTEM

7

Rocker

Rod Reducerwith Rod Reducer

Lever Arm

Plug/DTTStarter

Corkscrew

PlugIntroducer

Plug/Set ScrewStarter

LOW PROFILECROSSLINK® SYSTEM INSTRUMENTS

PlateTemplate

Hex HeadScrewdriver

PlateBenders

PlateHolder

Patient Position

The patient is placed in the prone position following induction

of anesthesia, intubation and placement of monitors. Care should

be taken in positioning to avoid pressure areas and compromise of

the abdomen (Fig. 1). The patient is then prepped and draped

in the usual manner.


STEP 1

8

Fig. 1

Incision and Exposure

The skin and subcutaneous tissue are incised longer than the

planned fusion. Once bleeding is controlled, the exposure is

deepened through the fascial level and dissection is carried

out laterally to the transverse processes (Fig. 2).


STEP 2

9

Fig. 2

Hook Placement

As previously noted in this manual, the CD HORIZON® Spinal System

offers a number of anatomic top loading hooks of different shapes

and sizes. However, any CD HORIZON hook may be treated as a

closed hook simply by placing the break-off set screw into the

hook prior to insertion of the rod. The surgeon must choose the

appropriate hook based on the individual patient’s anatomy, deformity

type, method of correction, and direction of force application in

order to provide proper purchase on the vertebrae.

Pedicle Hook

The pedicle hook may be applied from T1 through T10. The hook

shoe direction is always cephalad and is in the infralaminar position.

The facet capsule is divided, and a portion of the inferior facet

process may be removed to facilitate insertion of the hook (Fig. 3).

The pedicle finder is used to localize the pedicle (Fig 4). Once the

pedicle has been clearly identified, the hook may be inserted either

with an implant holder or with the dual purpose instrument.

The appropriate hook pusher should be utilized to facilitate

placement of the hook.


STEP 3

10

Fig. 3

Fig. 4

Supralaminar Position

The direction of this hook is always caudal. A small laminotomy

and division of the ligamentum flavum is carried out on the superior

lamina. The laminar elevator may be used to dissect the ligamentum

flavum from the lamina. The amount of bone removed from the

lamina may vary depending on the size of the hook to be utilized.

The inferior edge of the lamina above may also be removed to

permit easier placement of this hook. An implant holder is used to

insert the hook. If necessary a small lamina spreader may be used

to enlarge the opening while inserting the hook.

Infralaminar Position

This hook is always inserted in the cephalad direction and is

generally used at T10 or below. Again, a small laminotomy with

division of the ligamentum flavum is performed. The laminar

elevator may be used to facilitate hook placement. The implant

holder with hook pusher can be utilized to promote

hook insertion.


STEP 3

11

Hook Placement (continued)

Transverse Process Position

This generally is a wide blade hook and is usually used in a

claw construct. It may be placed in a cephalad or caudad

direction. Generally the hook is placed in the caudad direction.

The transverse process elevator is used to start placement of this

hook by dissecting the soft tissues from the superior aspect of

the transverse process. The hook is held by an implant holder

during insertion.

NOTE: All hooks should be continuously checked during the insertion process to ensure that they remain in the correct position. Facet fusion may be performed in a standard manner following implantation of the hooks (Fig. 5).


STEP 3

12

Fig. 5

Rod Contouring

The appropriate size rod is measured and cut to the correct length

outside the operative field. To achieve the correct sagittal plane

contour, the rod is bent in small incremental steps using a french

bender (Fig. 6). At this point, bone graft harvesting and decortication

may take place. The low profile of the CD HORIZON® spinal

implants make decortication possible even after the construct

is assembled.


STEP 4

13

Fig. 6

Rod Insertion

The rod is then entered into the top loading implants beginning

from either the cephalad or caudad directions (Fig. 7). The break-off

set screw (hereafter referred to as the “plug”) is inserted into the

implant either with the free hand method using the plug starter

or with a plug introducer instrument. The rod is best inserted using

the appropriate rod holder.


STEP 5

14

Fig. 7

Provisional Implant Closure

Method 1

If the rod is laying in the bottom of the implant groove, the plug

may be seated into the top of the implant using the free hand

technique with the plug starter (Fig. 8). The plug starter is turned

counterclockwise until an audible “click” occurs to limit the

possibility of cross-threading. The rod may also be pushed into the

implant with a rod pusher. However, the implant should be

controlled during this process. The lateral implant holder is especially

effective in maintaining implant control while pushing the rod into

the bottom of the implant (Fig. 9). The plug starter can be used to

place the plug into the implant when using either the lateral implant

holder or the curved implant holder.


STEP 5

15

Fig. 8

Fig. 9

LateralImplant Holder

Rod Insertion (continued)

Method 2

An alternative method of reducing the rod into the implant when

only a slight height difference exists between the rod and implant is

to use the rocker instrument. This instrument allows the rod to be

seated into the bottom of the implant (Fig. 10a). The implant is

grasped from the sides with the rocker cam above the rod. The

rocker is rotated backward thereby levering the rod into the implant

groove (Fig. 10b). The plug starter is then used to attach the plug.


STEP 5

16

Fig. 10a

Fig. 10b

Method 3

The plug introducer instrument can be used when additional force

is needed to seat the rod into the implant. This instrument is placed

over the rod with its “flanges” parallel to the rod. The tines of the

plug introducer are positioned over the rod and the implant (Fig. 11a).

The sleeve of the plug introducer is then turned clockwise to secure

the implant to the instrument (Fig. 11b). Visually inspect to ensure

that the plug introducer is securely attached to the implant.


STEP 5

17

Fig. 11a Fig. 11b

Flanges

Sleeve


Method 3 (continued)

Either one or two corkscrew devices are attached to the flanges of

the plug introducer and the rod is driven into the top loading implant

(Fig. 11c). To verify that the rod is fully seated in the implant, inspect

visually or place the provisional plug driver into the cannulation of

the plug introducer. Check to see that the uppermost etching mark

on the shaft of the plug driver is completely inside the cannulation

of the plug introducer. If the etching mark is not completely inside the

introducer then the corkscrews must be turned further to fully seat

the rod (Fig. 11d). Once the etching mark is confirmed to be entirely

inside the introducer (Fig. 11e), then the driver can be removed.


STEP 5

18

Fig. 11c Fig. 11d Fig. 11e

Indicates:Rod not

fully seated

Indicates:Rod fully

seated

The plug implant is then placed into the cannulation of the

introducer and secured with the provisional plug driver (Fig. 12).

The plug driver instrument is again placed in the cannulation of

the introducer and matched to the hex drive of the plug. The

provisional plug driver is turned counterclockwise until an audible

“click” and a palpable slight dropping of the instrument is noted.

This ensures that the thread of the plug is lined up with the thread

of the implant and limits the possibility of cross-threading (Fig. 13).

An alternative method is to seat the plug on the plug starter

instrument and then insert the instrument (with plug) into the

cannulation of the plug introducer. Again, the plug starter is turned

counterclockwise until the “click” is noted. The plug is then seated

in the implant. The provisional plug driver is used to temporarily

lock the rod to the implant. Enough force can be generated by

the pear-shaped handle of the provisional plug driver to maintain

secure closure of the implant without breaking off the head of

the plug. The provisional plug driver may be used to loosen and

tighten the implant closure for all compression/distraction or

rotation maneuvers.


STEP 5

19

Fig. 12

Fig. 13


Method 4

Occasionally the rod lies medial or lateral to the implant channel

and controlled translation would be helpful. The rod reducer

instrument and the accompanying lever arm may be used in these

situations. The tines of the rod reducer are attached to a side of the

hook in a manner similar to that of the lateral implant holder. By

holding the coupling sleeve and stabilizing bar, position the tines of

the instrument over the side of the implant body with the open

side facing the rod. Once the tines are in position, hold the rod

reducer steady with the stabilizing bar and slide the coupling sleeve

downward until the implant is properly engaged (Fig. 14a). With

the implant contained, turn the threaded knob at least one full

clockwise revolution; now the implant may be manipulated by the

rod reducer. For translation of a laterally positioned rod, attach the

lever arm to the coupling sleeve axles. Turn the threaded knob

while manipulating the lever arm with a sweeping motion to

capture the rod (Fig. 14b).


STEP 5

20

Fig. 14a

ThreadedKnob

CouplingSleeve

Axle

StabilizingBar

Fig. 14b


STEP 5

21

Fig. 14c Fig. 14d Fig. 14e

Manually translate the rod until it is above the channel of the implant (Fig. 14c).

Turn the threaded knob in a clockwise manner until the rod is captured in the

implant channel. The lever arm may now be removed. Continue tightening the

threaded knob until complete rod reduction is achieved. The provisional plug

driver may be used to confirm the rod position in

the implant channel (Fig. 14d).

Use the plug starter to introduce the plug into

the implant channel (Fig. 14e). Turn the plug starter

counterclockwise until an audible “click” is noted.

The provisional plug driver is used to temporarily

lock the rod within the implant.

NOTE: If the rod is directly above the hook or screw channel, the rod reducer may be used without the lever arm.

Fig. 15

Force Application/Rod Rotation

Force application is achieved by the curved compressor or curved

spreader instruments. Care should be taken to ensure that the feet

of either instrument are placed against the implant body and not

against the plug (Fig. 15). Failure to do this may result in slippage of

the implant or premature breaking of the plug. The provisional plug

driver may be used to maintain temporary locking and security

of the rod/implant construct. Temporary fixation of the implant

may be done numerous times without damage to either the plug

or implant threads. If the plug has been tightened in a cross-

threaded position, it should be removed and replaced.

As necessary, the rod may be rotated with the power grip

and/or hex rotation wrench instruments. C-ring instruments may

be placed to maintain hook position while allowing rotation of the

rod. Hooks should be checked for alignment following rotation

maneuvers and the necessary forces should be applied to

resecure the implants if needed.


STEP 6

22

Bone Grafting and Crosslink® PLATING

Decortication and bone grafting can now take place. Low Profile

CROSSLINK® Plates may also be added at this time.

After tightening the plugs, the appropriate size Low Profile

CROSSLINK Plate or CROSSLINK Multi-Span® Plate is determined

with the measuring template (Fig. 16). Rods may be spread or

compressed as necessary.

With use of the plate holder (810-510), the appropriate Low Profile

CROSSLINK Plate or Multi-Span Plate is selected and pressed down

onto the rods (Fig. 17).

Plate benders should be used to contour the Low Profile

CROSSLINK Plates or the Multi-Span Plates. When bending the

Low Profile CROSSLINK and Multi-Span Plates, do not exceed

20° in any single plane.

The set screws are advanced using the screwdriver to a torque of

approximately 60 in-lbs., alternating tightening from side to side to

ensure uniform closure (if using a CROSSLINK Multi-Span Plate, the

midline screw is tightened after the set screws are secured). Two

screwdrivers may be used simultaneously to advance the set

screws for uniform closure.

NOTE: The Low Profile CROSSLINK Plates are part of the TSRH® Spinal System,the 6.35mm Stainless Steel and Titanium and 5.5mm Stainless Steel LowProfile CROSSLINK Multi-Span Plates are part of the CD HORIZON® SpinalSystem and the 5.5mm Titanium Low Profile CROSSLINK Multi-Span Platesare part of the Medtronic Sofamor Danek Multi Axial Screw System.


STEP 7

23

Fig. 16

Fig. 17

Bone Grafting and Crosslink® PLATING (continued)

If it is necessary to contour the Low Profile CROSSLINK®

Multi-Span® Plate, follow these steps:

• Shorten the telescopic mechanism slightly less than the

span between the rods and provisionally tighten the

midline set screw.

• Bend the plate as required using the plate benders.

However, do not exceed 20° in any single plane.

• Loosen the midline set screw and apply the CROSSLINK

Plate as stated above.


STEP 7

24

Final TighteningAND CLOSURE

When all implants are securely seated in place, final tightening

and break off of the head of the plug is done. The counter torque

device is placed over the implant and rod (Fig. 18a) while the final

plug driver is inserted through the cannulation of the counter torque.

The T-handle provides adequate leverage for the break off of the

plug head between 11-14N-m. The handle of the counter torque

device should be held to prevent torquing of the construct while

the plug is secured and broken (Fig. 18b). If necessary, the internal

plug may be removed using the modular T-25 Shaft and Handle

(Fig. 19). Once a plug has been removed, it should be discarded

and replaced with a new one.

Wound closure is then performed in the customary manner.


STEP 8

25

Fig. 18a Fig. 18b Fig. 19

IMPORTANT INFORMATION ONTHE CD HORIZON® SPINAL SYSTEMPURPOSE:

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinalsegments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

DESCRIPTION:The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws,

CROSSLINK® Plates, staples and connecting components, as well as implant components from otherMEDTRONIC SOFAMOR DANEK spinal systems, which can be rigidly locked into a variety of configurations,with each construct being tailor-made for the individual case.

Certain implant components from other MEDTRONIC SOFAMOR DANEK spinal systems can be used withthe CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates,CROSSLINK® plates, connectors, staples and washers, GDLH® rods, hooks, connectors and CROSSLINK®

bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS™ bolts. Please note that certain compo-nents are specifically designed to connect to φ4.5mm, φ5.5mm, or φ6.35mm rods, while other componentscan connect to both φ 5.5mm rods and φ 6.35 mm rods. Care should be taken so that the correct compo-nents are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON®

ECLIPSE™ rods and screws are intended for anterior use only.The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel

described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire systemmay be made out of medical grade titanium or titanium alloy described by such standards as ASTM F67 orASTM F136 or ISO 5832-3 or 5832-2. MEDTRONIC SOFAMOR DANEK expressly warrants that these devicesare fabricated from one of the foregoing material specifications. No other warranties, express or implied, aremade. Implied warranties of merchantability and fitness for a particular purpose or use are specificallyexcluded. Never use stainless steel and titanium implant components in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol –NiTi). Shape Memory Alloy is compatible with titanium implants only. Do not use with stainless steel.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with com-ponents from any other system or manufacturer unless specifically allowed to do so in this or anotherMEDTRONIC SOFAMOR DANEK document. As with all orthopaedic and neurosurgical implants, none of theCD HORIZON® Spinal System components should ever be reused under any circumstances.

.

INDICATIONS, CONTRAINDICATIONS AND POSSIBLE ADVERSE EVENTS:INDICATIONS:When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON®

CANNULATED M8 MULTI-AXIAL SCREW components are intended for the following indications:When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIALSCREW components are intended for the following indications: (1) degenerative disc disease (as defined byback pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographicstudies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., degenerative scoliosis, kypho-sis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.In addition, when used as a pedicle screw fixation system, the CD HORIZON® CANNULATED M8 MULTI-AXIALSCREW components are also indicated for skeletally mature patients: (a) having severe spondylolisthesis(Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions usingautogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine(L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.The CD HORIZON® ECLIPSE™ components are intended for the following indications:When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for thefollowing indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degen-eration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondy-lolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis,(7) tumor resection, and/or (8) failed previous fusion.The CD HORIZON® system is also intended for the following indications:When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients,the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolis-thesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kypho-sis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated forskeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral(L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are havingthe device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the deviceremoved after the development of a solid fusion mass.When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal Systemis intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenicorigin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal steno-sis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6)pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

CONTRAINDICATIONS:Contraindications include, but are not limited to:

1. Active infectious process or significant risk of infection (immunocompromise).2. Signs of local inflammation.3. Fever or leukocytosis. 4. Morbid obesity.5. Pregnancy.6. Mental illness.7. Grossly distorted anatomy caused by congenital abnormalities.8. Any other medical or surgical condition which would preclude the potential benefit of spinal implant

surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained byother diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.

9. Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Osteoporosis orosteopenia is a relative contraindication since this condition may limit the degree of obtainable

correction, stabilization, and/or the amount of mechanical fixation.10. Suspected or documented metal allergy or intolerance.11. Any case not needing a bone graft and fusion.12. Any case where the implant components selected for use would be too large or too small to achieve a

successful result. 13. Any case that requires the mixing of metals from two different components or systems.14. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.15. Any patient in which implant utilization would interfere with anatomical structures or expected physio-

logical performance.16. Any patient unwilling to follow postoperative instructions.17. Any case not described in the indications.

POTENTIAL ADVERSE EVENTSAll of the possible adverse events associated with spinal fusion surgery without instrumentation are possible.

With instrumentation, a listing of potential adverse events includes, but is not limited to:1. Early or late loosening of any or all of the components.2. Disassembly, bending, and/or breakage of any or all of the components.3. Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or

general corrosion), including metallosis, staining, tumor formation, and/or autoimmune disease.4. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant

possibly causing skin penetration, irritation, fibrosis, necrosis, and/or pain. Bursitis. Tissue or nervedamage caused by improper positioning and placement of implants or instruments.

5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.6. Infection.7. Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.8. Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete),

dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the develop-ment or continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, and/orvisual deficits.

9. Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, para-paresis, reflex deficits, irritation, arachnoiditis, and/or muscle loss.

10. Urinary retention or loss of bladder control or other types of urological system compromise.11. Scar formation possibly causing neurological compromise or compression around nerves and/or pain.12. Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum,

pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below thelevel of surgery. Retropulsed graft.

13. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.14. Non-union (or pseudarthrosis). Delayed union. Mal-union.15. Cessation of any potential growth of the operated portion of the spine.16. Loss of or increase in spinal mobility or function.17. Inability to perform the activities of daily living.18. Bone loss or decrease in bone density, possibly caused by stresses shielding.19. Graft donor site complications including pain, fracture, or wound healing problems.20. Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise.21. Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleed-

ing, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardio-vascular system compromise.

22. Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.23. Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.24. Change in mental status.25. Death.

Note: Additional surgery may be necessary to correct some of these potential adverse events.

WARNING AND PRECAUTIONS:WARNING: The safety and effectiveness of pedicle screw spinal systems have been established only for

spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation.These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spinesecondary to degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dis-location, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effec-tiveness of this device for any other conditions are unknown.

PRECAUTION: The implantation of pedicle screw spinal systems should be performed only by experiencedspinal surgeons with specific training in the use of this pedicle screw spinal system because this is a techni-cally demanding procedure presenting a risk of serious injury to the patient.

A successful result is not always achieved in every surgical case. This fact is especially true in spinalsurgery where many extenuating circumstances may compromise the results. This device system is notintended to be the sole means of spinal support. Use of this product without a bone graft or in cases thatdevelop into a non-union will not be successful. No spinal implant can withstand body loads without the sup-port of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will eventuallyoccur.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, andproper selection and placement of the implants are important considerations in the successful utilization ofthe system by the surgeon. Further, the proper selection and compliance of the patient will greatly affect theresults. Patients who smoke have been shown to have an increased incidence of non-unions. These patientsshould be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abusepatients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerveparalysis are also poor candidates for spine fusion.PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and thepatient, the indications, contraindications, warnings and precautions given in this document must be con-veyed to the patient.CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.CAUTION: FOR USE ON OR BY THE ORDER OF A PHYSICIAN ONLY.

Other preoperative, intraoperative, and postoperative warnings and precautions are as follows:Implant Selection:The selection of the proper size, shape and design of the implant for each patient is crucial to the success

of the procedure. Metallic surgical implants are subject to repeated stresses in use, and their strength is lim-ited by the need to adapt the design to the size and shape of human bones. Unless great care is taken inpatient selection, proper placement of the implant, and postoperative management to minimize stresses on

the implant, such stresses may cause metal fatigue and consequent breakage, bending or loosening of thedevice before the healing process is complete, which may result in further injury or the need to remove thedevice prematurely.

PREOPERATIVE:1. Only patients that meet the criteria described in the indications should be selected.2. Patient conditions and/or pre dispositions such as those addressed in the aforementioned contraindica-

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

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

4. An adequate inventory of implants should be available at the time of surgery, normally a quantity inexcess of what is expected to be used.

5. Since mechanical parts are involved, the surgeon should be familiar with the various components beforeusing the equipment and should personally assemble the devices to verify that all parts and necessaryinstruments are present before the surgery begins. The CD HORIZON® Spinal System components(described in the DESCRIPTION section) are not to be combined with the components from anothermanufacturer. Different metal types should never be used together.

6. All components and instruments should be cleaned and sterilized before use. Additional sterile compo-nents should be available in case of an unexpected need.

INTRAOPERATIVE:1. Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will

cause loss of neurological functions.2. Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or

operative personnel.3. The rods should not be repeatedly or excessively bent. The rods should not be reverse bent in the same

location. Use great care to insure that the implant surfaces are not scratched or notched, since suchactions may reduce the functional strength of the construct. If the rods are cut to length, they shouldbe cut in such a way as to create a flat, non-sharp surface perpendicular to the midline of the rod. Cutthe rods outside the operative field. Whenever possible, use pre-cut rods of the length needed.

4. Whenever possible or necessary, an imaging system should be utilized to facilitate surgery.5. To insert a screw properly, a guide wire should first be used, followed by a sharp tap. 6. Caution: Do not overtap or use a screw/bolt that is either too long or too large. Overtapping or using

an incorrectly sized screw/bolt may cause nerve damage, hemorrhage, or the other possible adverseevents listed elsewhere in this package insert. If screws/bolts are being inserted into spinal pedicles, useas large a screw/bolt diameter as will fit into each pedicle.

7. Bone graft must be placed in the area to be fused and graft material must extend from the upper to thelower vertebrae being fused.

8. To assure maximum stability, two or more CROSSLINK® plates or DTT Transverse Links on two bilater-ally placed, continuous rods, should be used whenever possible.

9. Bone cement should not be used because the safety and effectiveness of bone cement has not beendetermined for spinal uses, and this material will make removal of the components difficult or impossi-ble. The heat generated from the curing process may also cause neurologic damage and bone necrosis.

10. Before closing the soft tissues, all of the nuts or screws should be tightened firmly. Recheck the tight-ness of all nuts or screws after finishing to make sure that none loosened during the tightening of theother nuts or screws. Failure to do so may cause loosening of the other components.

POSTOPERATIVE:The physician's postoperative directions and warnings to the patient, and the corresponding patient

compliance, are extremely important.1. Detailed instructions on the use and limitations of the device should be given to the patient. If partial

weight-bearing is recommended or required prior to firm bony union, the patient must be warned thatbending, loosening and/or breakage of the device(s) are complications which may occur as a result ofexcessive or early weight-bearing or muscular activity. The risk of bending, loosening, or breakage of atemporary internal fixation device during postoperative rehabilitation may be increased if the patient isactive, or if the patient is debilitated or demented. The patient should be warned to avoid falls or sud-den jolts in spinal position.

2. To allow the maximum chances for a successful surgical result, the patient or devices should not beexposed to mechanical vibrations or shock that may loosen the device construct. The patient should bewarned of this possibility and instructed to limit and restrict physical activities, especially lifting andtwisting motions and any type of sport participation. The patient should be advised not to smoke tobac-co or utilize nicotine products, or to consume alcohol or non-steroidals or anti-inflammatory medica-tions such as aspirin during the bone graft healing process.

3. The patient should be advised of their inability to bend or rotate at the point of spinal fusion and taughtto compensate for this permanent physical restriction in body motion.

4. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses onthe implant. By the mechanism of fatigue, these stresses can cause the eventual bending, loosening, orbreakage of the device(s). It is important that immobilization of the spinal surgical site be maintaineduntil firm bony union is established and confirmed by roentgenographic examination. If a state of non-union persists or if the components loosen, bend, and/or break, the device(s) should be revised and/orremoved immediately before serious injury occurs. The patient must be adequately warned of these haz-ards and closely supervised to insure cooperation until bony union is confirmed.

5. As a precaution, before patients with implants receive any subsequent surgery (such as dental proce-dures), prophylactic antibiotics may be considered, especially for high-risk patients.

6. The CD HORIZON® Spinal System implants are temporary internal fixation devices. Internal fixationdevices are designed to stabilize the operative site during the normal healing process. After the spine isfused, these devices serve no functional purpose and may be removed. While the final decision onimplant removal is, of course, up to the surgeon and patient, in most patients, removal is indicatedbecause the implants are not intended to transfer or support forces developed during normal activities.If the device is not removed following completion of its intended use, one or more of the following com-plications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant posi-tion, possibly resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending,loosening and breakage, which could make removal impractical or difficult; (5) Pain, discomfort, orabnormal sensations due to the presence of the device; (6) Possible increased risk of infection; (7) Boneloss due to stress shielding; and (8) Potential unknown and/or unexpected long term effects such as car-cinogenesis. Implant removal should be followed by adequate postoperative management to avoid frac-ture, re-fracture, or other complications.

7. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is notpossible. As with all orthopedic implants, the CD HORIZON® Spinal System components should neverbe reused under any circumstances.

PACKAGING:Packages for each of the components should be intact upon receipt. If a loaner or consignment system is

used, all sets should be carefully checked for completeness and all components including instruments shouldbe carefully checked to ensure that there is no damage prior to use. Damaged packages or products shouldnot be used, and should be returned to MEDTRONIC SOFAMOR DANEK.

CLEANING AND DECONTAMINATION:All instruments and implants must first be cleaned using established hospital methods before sterilization

and introduction into a sterile surgical field. Additionally, all instruments and implants that have been previ-ously taken into a sterile surgical field must first be decontaminated and cleaned using established hospitalmethods before sterilization and reintroduction into a sterile surgical field. Cleaning and decontamination caninclude the use of neutral cleaners followed by a deionized water rinse.Note: certain cleaning solutions such as those containing caustic soda, formalin, glutaraldehyde, bleachand/or other alkaline cleaners may damage some devices, particularly instruments; these solutionsshould not be used.Also, certain instruments may require dismantling before cleaning.

All products should be treated with care. Improper use or handling may lead to damage and possibleimproper functioning of the device.

STERILIZATION:Unless marked sterile and clearly labeled as such, the CD HORIZON® Spinal System components, as well

as those implants from other MEDTRONIC SOFAMOR DANEK spinal systems specifically indicated for usewith the CD HORIZON® Spinal System, described in this insert are provided non-sterile and must be steril-ized prior to use. These products are recommended to be steam sterilized by the hospital using one of thethree sets of process parameters below:NOTE: The following note applies to the process parameter identified with the ** below:For use of this product and instruments outside the United States, some non-U.S. Health Care Authorities rec-ommend sterilization according to these parameters so as to minimize the potential risk of transmission ofCreutzfeldt-Jakob disease, especially of surgical instruments that could come onto contact with the centralnervous system.

METHOD CYCLE TEMPERATURE EXPOSURE TIME

Steam Gravity 250° F (121° C) 30 Minutes

**Steam Gravity 273° F (134° C) 18 Minutes

Steam Pre-Vacuum 270° F (132° C) 4 Minutes

Remove all packaging materials prior to sterilization. Use only sterile products in the operative field.

PRODUCT COMPLAINTS:Any Health Care Professional (e.g. customer or user of this system of products), who has any complaint

or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effec-tiveness and/or performance, should notify the distributor or MEDTRONIC SOFAMOR DANEK. Further, if anyof the implanted CD HORIZON® Spinal System component(s) ever "malfunctions". (i.e., does not meet any ofits performance specifications or otherwise does not perform as intended), or is suspected of doing so, thedistributor should be notified immediately. If any MEDTRONIC SOFAMOR DANEK product ever "malfunctions"and may have caused or contributed to the death or serious injury of a patient, the distributor should be noti-fied immediately by telephone, fax or written correspondence. When filing a complaint please provide thecomponent(s) name, part number, lot number(s), your name and address, the nature of the complaint, andnotification of whether a written report for the distributor is requested.

FURTHER INFORMATION:In case of complaint , or for supplementary information, or further directions for use of this system,

please see the address page on this information sheet.

©2000 MEDTRONIC SOFAMOR DANEK, Inc. All rights reserved.

For product availability, labeling limitations, and/or more information on any MedtronicSofamor Danek products, contact your MEDTRONIC SOFAMOR DANEK USA Sales Associate,

or call MEDTRONIC SOFAMOR DANEK USA Customer Service toll free: 800-933-2635.

MEDTRONIC SOFAMOR DANEK USA1800 Pyramid Place Memphis, TN 38132

(901) 396-3133 Fax: (901) 332-3920 Wats: (800) 876-3133Customer Service: (800) 933-2635

www.sofamordanek.com

See package insert for labeling limitations.

©2000 Medtronic Sofamor Danek. All Rights Reserved. Patents Pending. LIT.CDH.ST96 REV.C 9/00

cd horizon surg tech revision - mt ortho

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