mantis redux surgical technique -...

MANTIS® ReduxSurgical Technique

LITe®

Less Invasive Technologies

Table of Contents

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Key Design Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6Patient Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6K-Wire Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Dilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Pedicle Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Screw Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16To assemble the Polyaxial Screwdriver: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Screw Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Screw Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Rod Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Blocker Inserter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Compression and Distraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Construct Tightening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Catalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

MANTIS Redux Spinal SystemSurgical Technique

IntroductionOne primary objective of Stryker Spine's Less Invasive Technologies (LITe) is toreplicate the clinical results of the corresponding open procedure.

At the moment there is insufficient data to show that minimally invasive spinesurgery provides any short and long term benefit to patients when compared totraditional spine surgery.

Important This Surgical Technique sets forth detailed, recommended procedures for using theMANTIS Redux Spinal System. It offers guidance that you should heed but as withany such technical guide, each surgeon must consider the particular needs of eachpatient and make appropriate adjustments when necessary and as required.

Always refer to the package insert, product label and/or instructions before using anyStryker implant or instrument.

Note: No acid or alkaline solvents should be used in the cleaning of anodizedcomponents.

Note: Upon the completion of each surgical procedure, use adequate suction andirrigation to ensure the removal of any existing non-implantable materials.

Note: This is intended as a guide only. There are multiple techniques, and as withany surgical procedure, a surgeon should be thoroughly trained before proceeding.


AcknowledgmentsStryker Spine wishes to thank the following physicians forauthoring this surgical technique.

Dan Cohen, MD

Nils Hansen-Algenstaedt, MD

Terrence Julien, MD

Reginald Knight, MD

Jeffrey Roh, MD

Key Design Features

Titanium PolyaxialReduction Screws

1) 4.5mm x 25-45mm2) 5.5mm x 30-55mm3) 6.5mm x 30-60mm4) 7.5mm x 30-90mm5) 8.5mm x 30-90mm

Xia® 3 Bone Screw Cannulated Xia 3 design offers a much more rigidconnection to the screwdriver.

Intraoperative RodOptions

Accepts Titanium and Vitallium rods in 5.5mm and6.0mm diameters.

Low Profile The tulip is lower profile than the MANTIS screwheadwhen broken off.

Spondy Reduction The surgeon should be able to reduce a spondy with the implant.

Guaranteed RodSeating

Provides for a larger margin of error when introducingthe rod. The surgeon can use the implant to fully seatthe rod every time.

Reduction TabRemoval Instrument

Self guiding instrument that can be used to break offand remove tabs percutaneously.

Device Comments

Figure 1

Figure 2A

Figure 2B

Patient Positioning

MANTIS Redux can be used under local, epidural,spinal or general anesthesia. General anesthesia iscommonly used since it is the most comfortable for thepatient and allows immediate postoperativeneurological assessment.

t The patient is prepped and draped in the usualsterile manner for posterior fusion with pediclescrew fixation.

6

Markings

t Using A/P imaging, place the K-Wire transverselyacross the mid-line of the cephalad pedicles.


Patient

Positioning

Instrument Bar

7

Patient

Positioning

Figure 3B

Figure 3A

t Repeat for additional pedicles.

Sharp 48230230Blunt 48230231K-Wire

Figure 4

Figure 5

Figure 6

Carefully determine the appropriate entry point andtrajectory for the MANTIS Redux Screw.

t For pedicle screws, the entry point is approximately4cm off mid-line with a more lateral trajectory.

t Incise the skin. A fascial incision may be done tomake tissue dilation easier.

Note: If tissue dilation is difficult, increase the fascialincision.

8

K-Wire Insertion

t Insert the Jam Shidi through the skin incision to theintersection of the facet and transverse process.

t Confirm that the appropriate pedicle starting placehas been determined using both A/P and lateralimages.

Note: The diameter of the MANTIS K-Wire is 1.3mm.

Note: The Radius K-Wire is not compatible with theMANTIS Spinal System.

t Use the Jam Shidi needle to gain access to thepedicle.

t After placing the Jam Shidi at the intersection of thefacet and the transverse process, the needle may beadvanced partially through the pedicle using theSlap Hammer.


K-W

ire

Inse

rtion

Patient

Positioning

Figure 7

Instrument Bar

9

t As the pedicle is navigated with the Jam Shidi, itshould approach the medial wall of the pedicle onthe A/P view and should approach the base of thepedicle on the lateral view.

Figure 8

t When the needle reaches the medial wall on the A/Pview, verification needs to be performed in thelateral view to ensure that the needle is past the baseof the pedicle.

K-W

ire

Inse

rtion

Patient

Positioning

10 Gauge, 9 inch 4823711010 Gauge, 5 inch 4823710511 Gauge, 5 inch 4823711513 Gauge, 5 inch 48237135Jam Shidi

48237120Slap Hammer


Figure 9

Figure 10

Figure 11

t Remove the inner trocar of the Jam Shidi.

10

t The removal of the Jam Shidi inner trocar allows theK-Wire to be inserted into the pedicle.

t Caution should be practiced with regard to theposition of the K-Wire in order to avoid theadvancement of the K-Wire.

Note: The K-Wire is a single use instrument.

Note: The Radius K-Wire is not compatible withMANTIS products.

Use the K-Wire Guide Tube to prevent the K-Wirefrom bending or moving during insertion.

t Place the K-Wire Guide Tube over the K-Wire anddock on the Jam Shidi.

t Use the Slap Hammer to impact the K-Wire.


K-W

ire

Inse

rtion

Figure 12

Instrument Bar

11

t Once the K-Wire is inserted, remove the outer shaftof the Jam Shidi.

t Hold the K-Wire in position when removing theJam Shidi.

K-W

ire

Inse

rtion

48237120Slap Hammer

10 Gauge, 9 inch 4823711010 Gauge, 5 inch 4823710511 Gauge, 5 inch 4823711513 Gauge, 5 inch 48237135Jam Shidi


48230235K-Wire Guide Tube

Figure 13

Figure 14

Figure 15

Dilation

t Place the Slim Dilator over the K-Wire, through theincision.

t Advance the Slim Dilator, over the K-Wire, throughthe tissue twisting clockwise while directing ittoward the pedicle.

t The Slim Dilator is advanced through thelumbodorsal fascia.

t Location of the Slim Dilator is confirmed usingimaging.

t Note the depth marking of the Slim Dilator inrelation to the skin.

Note: Feel, fluoroscopy, anatomical knowledge, reviewof preoperative images and partial visualization may allcontribute towards desired instrument placementaccuracy.

Note: The dilators have depth markings laser etchedwhich correlate to the blade lengths.

t Choose a Redux Blade length based on where thetop of the skin meets the Slim Dilator.

Note: If the skin is exactly on the marking on the SlimDilator, choose the longer blade size.

12

t Sequentially slide Dilator 2, Dilator 3 and theHollow Dilator over the Slim Dilator to sequentiallypenetrate and gently dissect soft tissue down to thepedicle.

t Twist the dilators clockwise during insertion toengage the thread features.


Dilation

Figure 16

Instrument Bar

13

t Remove the initial dilators after inserting theHollow Dilator.

t The Hollow Dilator remains in place as the workingchannel for pedicle preparation.

Dilation


48280102Hollow Dilator

48280105Slim Dilator

48280106Dilator 2

48280107Dilator 3

Size 1 3-5cm 48289035Size 2 5-7cm 48289057Size 3 7-9cm 48289079Size 4 9-11cm 48289911Size 5 11-13cm 48289113Redux Blade

Figure 17

Figure 18

Figure 19

Pedicle Preparation

t With the Hollow Dilator still in place, prepare thepedicle by placing the Cannulated Modular Awlover the K-Wire and impact into the pedicle with atwisting motion.

t Hold the K-Wire in position when removing theawl.

t Use the cannulation of the Slap Hammer to impactthe awl.

Note: The awl has a stop at 12mm.

14

t If the bone is too hard, the appropriate tap may beused to prepare the pedicle.

t The Cannulated Modular Taps are designed to beused with the Tap Sleeve and laser etched with5mm intervals to help indicate the depth at whichthe tap has been inserted. This is designed to helpdetermine proper screw length.

Note: The length of the taps thread is 25mm.

Note: The Cannulated Modular Taps are intended tobe used with the MANTIS Tap Sleeve. This techniquewill not work with the Xia Precision Tap Sleeve, as itis shorter.

Note: The Tap Sleeve is not compatible with the 8.5mm Tap.

t As an instrument advances into the pedicle, theproximal end of the instrument will move relative tothe markings on the K-Wire. If this does not occur,the surgeon should stop and fluoroscopy should beused to verify the position of the K-Wire.

Note: 1cm interval markings on the K-Wire provide thecannulated instruments change in depth in the pedicle.

Note: Cantilevering the Awl and Taps while in thepedicle may damage the instrument.


Dilation

Figure 20

Instrument Bar

15

t Check pedicle depth with either fluoroscopy or read the depthfrom the Tap Sleeve as it moves along the proximal edge of thetap. There are markings at 30mm, 40mm and 50mm.

Note: The Tap Sleeve is made of radiolucent Ultem Poly Ether Imide.

Note: Slide the Tap Sleeve proximal to the tap shaft to engage thefriction fit. This prevents the Tap Sleeve from sliding off the tap.

Figure 21

t Hold the K-Wire in position when removing the tap.

The Hollow Dilator can now be removed. Hold the K-Wire inposition when removing the Hollow Dilator.

Dilation

48280102Hollow Dilator


48237120Slap Hammer

48281164Cannulated Modular Awl

4.5mm 482811615.5mm 482811656.5mm 482811667.5mm 482811678.5mm 48281168Cannulated Modular Tap

48281315Tap Sleeve

Figure 22

Figure 23

Figure 24

Screw Insertion

With the pedicle pathways prepared and proper screwlength and diameter selected, the screw is prepared forinsertion.

Assemble each pair of Redux Blades into the ReduxScrew.

t Orient the screw so that the tulip posts are pointingup.

t Insert the appropriate size blade into each side ofthe tulip posts and spread apart.

Note: Blade size is chosen from the measurement takenfrom the dilator.

16

t Orient the Sliding Ring with the flat side down.

t Insert the blades through the bottom of the SlidingRing.

t Repeat this process for additional screws.

Note: If a lower profile is desired, the Slim Ring may beused as an alternative to the Sliding Ring.

Note: The MANTIS Redux Blades are not compatiblewith the MANTIS Persuader.


Screw

Inse

rtion

Instrument Bar

17

Figure 25

The 6 point star Screw head is designed:

t For faster and intuitive engagement with the Screwdriver.

t To prevent screwhead stripping.

t For reengagement for screw adjustments.

Screw

Inse

rtion

The MANTIS Redux Screws have 3 cuttingflutes to allow a surgeon to eliminate thetapping step. The screws may be insertedimmediately after the K-Wire is introduced.However, in most cases, tapping isrecommended.

48281201Slim Ring


Size 1 3-5cm 48289035Size 2 5-7cm 48289057Size 3 7-9cm 48289079Size 4 9-11cm 48289911Size 5 11-13cm 48289113Redux Blade

See CatalogLong Arm PA Screw

The Polyaxial Screwdriver allows for a rigidconnection between the screws and the screwdriver.

18

A primary design goal of the MANTIS Redux system isto improve the connection between the screwdriver andscrews. The screwdriver is improved to decrease toggleat 2 integral points of connection:

t Screwdriver to Screw Interface

t Screwdriver to Shaft Interface

The locking feature provides tactile, visual and audibleconfirmation that the screwdriver is securely locked.


Screw

Inse

rtion

Inner Shaft

Outer Shaft

Sleeve forScrewdriver

T-Handle

T-Handle Ratchet

Round Handle

Round Handle Ratchet

The Polyaxial Screwdriver can be connected to thefollowing Handles:

48289200 T-Handle Ratchet

48289300 Round Handle Ratchet

48289205 T-Handle Non-Ratchet

48289305 Round Handle Non-Ratchet

Figure 26

Instrument Bar

19

To assemble the Polyaxial Screwdriver:Step 1Press the “UNLOCK” button on the outer shaft.

Figure 27

Step 2Insert the Shaft for Polyaxial Screwdriver down theouter shaft.

Screw

Inse

rtion

Figure 28

Step 3Slide the sleeve for the screwdriver up the inner shaft. Verify thesleeve for screwdriver is completely bottomed out.

48289200T-Handle Ratchet

48289300Round Handle Ratchet

48289205T-Handle Non-Ratchet

48289305Round Handle Non-Ratchet

48289310Polyaxial Screwdriver

48289311Shaft for Polyaxial Screwdriver

Figure 29

Step 4Align the tabs and fully insert the quick connectmechanism into the shaft.

20

Figure 30

Step 5 Hold the screw by the threads and engage the tabs onthe inner shaft onto the saddle of the screw head.

Figure 31

Step 6Fully seat the inner shaft into the screwhead. Turn theouter shaft clockwise using the “LOCK” button untilthe threads are fully engaged.

Figure 32

Step 7 (Optional)If the ratchet sound is not present, confirm locking bypressing the “LOCK” Button.


Screw

Inse

rtion

Figure 33

Instrument Bar

21

Place the screwdriver over the K-Wire and insert intothe pedicle.

Figure 34

After driving the screw into the pedicle, remove theK-Wire to prevent it from advancing.

Screw

Inse

rtion


48289310Polyaxial Screwdriver

48289311Shaft for Polyaxial Screwdriver

Figure 35

Figure 36

Figure 37

Be certain that the screw is not inserted too far. If thepolyaxial head of the screw is driven to forcefullyagainst bone, it will lose its polyaxial capabilitiesmaking it difficult to connect the assemblies duringsubsequent steps.

Note: Use imaging and monitoring, as preferred, foradded information during bone screw insertion.

To disengage the screwdriver from the screw, press andrelease the “UNLOCK” button. Rotate outer shaftcounter-clockwise while firmly holding the handle.

Repeat the process for additional screws.

22

Screw Alignment

t Insert the Rod Contouring Shafts into the screwhead. The Rod Contouring Shafts should be firmlyseated into the screw heads.

Note: The laser markings on the Rod Contouring Shaftscorrespond to the blades to indicate that the shafts areproperly seated.

Note: It is recommended to use the Rod ContouringShafts when manipulating the screw heads.

Note: The polyaxial bone screws may provisionally lockupon insertion. With the Rod Contouring Shafts inplace, rotate the blades to unlock the heads beforeintroducing the rod.

Screw Adjustment

The screw heights may be adjusted as needed using thePoly Adjustment Driver. Use fluoroscopic images toconfirm.

The Poly Adjustment Driver can be inserted throughthe cannulas of the Rod Contouring Shafts.


Screw

Inse

rtion

Figure 38

Instrument Bar

23

t Align the Rod Contouring Shafts so that they are parallel.

t Attach the Rod Contouring Linkage to the Rod ContouringShafts. As needed, attach additional Rod Contouring Linkages,alternating sides.

Figure 39

t Lock the Rod Contouring Linkages into place by twisting thewing nut clockwise. The indicator should be flush on top.

Note: By locking the Rod Contouring Shafts in parallel, the top ofthe shafts reproduce the relative spacing of the screws above the skin.

Note: If the distance between screws is too great, use the ExtendedRod Contouring Linkage

Screw

Inse

rtion

48284030Rod Contouring Shaft

48289733Poly Adjustment Driver

48284035Rod Contouring Linkage

48284036Extended Rod Contouring Linkage

Figure 40

Figure 41

Figure 42

24

t Insert the rod percutaneously from either thecephalad or caudal side through the blades. Usingdirect visualization, guide the rod through each pairof blades.

Note: The rod is to be inserted from the open side ofthe Sliding Ring.


Rod

Inse

rtion

t Choose the appropriate length Rod and desired RodInserter.

t Insert the Rod Inserter Shaft into the Rod Inserter.

t Attach the appropriate Rod to the Rod Inserter. TheRod should be attached from the side of the RodInserter that has a groove in the handle.

Note: The MANTIS Hex End Rods are laser markedwith a dotted line to indicate their orientation. Ensurethat the line is facing up when attached to the RodInserter.

t Lock the Rod into position by twisting the knob onthe handle clockwise.

Note: When using the Adjustable Rod Inserter, attachthe Rod in the “0” position. The angle of the Rod maybe changed intraoperatively by turning the distal knobunder the handle. The Rod can be angled up to 20degrees.

Note: The Rod Inserter should be disassembled beforecleaning. To disassemble, press the button on thehandle and rotate the knob counter-clockwise.

Rod Insertion

The MANTIS Spinal System offers a comprehensiveselection of Rods and Rod Inserters. The MANTIS HexEnd Rods allow for a rigid connection between the Rodand Rod Inserter for easy insertion and manipulation.There are three types of Rod Inserters available:

• 90 degree fixed Rod Inserter

• 110 degree fixed Rod Inserter

• Adjustable Rod Inserter

Important Notes:Do Not excessively rotate the driving nut below 0° or above20° as this could cause the Rod Inserter to malfunction.Do Not hit on the Rod Inserter.The Rod Inserter should be properly lubricated between uses.

Figure 43

Instrument Bar

25

Note: Ensure that the Rod overhangs the distalscrewhead.

Figure 44

t The Rod Gripper may be used for adjustment of the rod.

t Insert the Rod Gripper down the blades. Squeeze thehandle to engage the rod.

t Manipulate the rod as needed.

Rod

Inse

rtion

48284055Rod Gripper

48281201Slim Ring

48480001 Adjustable48480111 110°48480091 90°

Rod Inserter

Figure 45

Figure 46

Figure 47

Blocker Inserter

t Use the Counter Torque Tube as an insertion tubeto facilitate alignment of the Blocker with the tulip.

Note: The laser markings on the Counter Torque Tubecorrespond to the blades to indicate that the instrumentis properly seated.

t Slide the Blocker Inserter and Blocker through theCounter Torque Tube and into the screw head.

Note: It is recommended to insert the most distalBlocker first.

t Rotate the Blocker clockwise to seat the blocker.

t Repeat for other bone screws.

Note: The Blocker Inserter is not intended to be usedfor final tightening.

26

t Once the rod is sufficiently captured in the screws,detach the Rod Inserter from the rod by turning theknob on the Rod Inserter counter-clockwise.

Note: There is a mechanical stop to indicate that theRod Inserter is fully disengaged.

Note: The Adjustable Rod Inserter should be lubricatedbetween use.

Note: The Rod Inserter is to be removed along the axisof the rod.

Compression and Distraction

t To achieve compression and distraction, insert theCompression & Distraction Shaft andCompression & Distraction Hinge through theblades and into the screw heads.

t Note the laser marking on the shafts to ensure thatthe shafts are fully seated.

Note: The Compression & Distraction Shaft and Hingeare to be oriented so that the eyelets are located on theoutside.


Blocker

Inse

rter

Compression

and Distraction

Figure 48

Instrument Bar

27

t Mate the tops of the Compression & DistractionShaft and Hinge using the connecting feature.

Figure 49

t To distract, insert the Distractor into the eyelets ofthe Compression & Distraction Shaft and Hinge.Squeeze the Distractor to apply the appropriatedistraction.

Blocker

Inse

rter

Compression

and Distraction

48289480Counter Torque Tube

48289999LITe Blocker

48287008Blocker Inserter

48289077Compression & Distraction Shaft

48289078Compression & Distraction Hinge

48480001 Adjustable48480111 110°48480091 90°

Rod Inserter

48281111Reduction Helper

In case of challenging blocker seating, aReduction Helper may be used. Removethe ring and replace with the ReductionHelper. It strengthens the Redux tuliparms during blocker insertion.Distraction/compression and constructtightening steps can be performed usingthe Reduction Helper in place.

Figure 50

t To compress, insert the Compressor into the eyelets of theCompression & Distraction Shaft and Hinge. Squeeze theCompressor to apply the appropriate distraction.

Note: The Compression & Distraction Shaft and Hinge arecannulated to allow for Blocker introduction.

28


Compression

and Distraction

Construct

Tightening

Tab

Removal

Figure 51

Construct Tightening

Once the correction procedures have been carried out and thespine is fixed in satisfactory position, the final tightening of theBlocker is done by utilizing the Counter Torque Tube andTorque Wrench.

t Dock the Counter Torque Tube on the screw.

t Note the depth markings on the Counter Torque Tube toensure that it is fully engaged with the screw.

t Insert the Torque Wrench into the Counter Torque Tube toengage the Blocker.

t Line up the two arrows on the Torque Wrench to achieve thebest possible torque of 12Nm for final tightening of theimplants.

Note: The Counter Torque Tube must be used for finaltightening. The Counter Torque Tube performs two importantfunctions:

1. It allows the Torque Wrench to align with the axis of thetightening axis.

2. It allows one to apply the torque needed to lock theimplant assembly without applying the torque to the restof the construct.

Note: If the Counter Torque Tube cannot be easily removed fromthe implant head, the rod may not be fully seated.

Note: The Xia Torque Wrench is not compatible with MANTISRedux.

Note: The ES2 Torque Wrench may also be used as an alternativeto the MANTIS Redux Torque Wrench to final tighten theblockers.

Note: Prior to final tightening, please ensure that:• The rod is horizontally placed into the screw head.• The rod is not high in the screw head.• An acute convex or concave bend is not contoured into the rod.

Figure 52

Instrument Bar

29

Tab Removal

Once final tightening has taken place, the MANTIS Redux screwtabs are broken off. A snap line allows a clean and easy break.

t Remove the Sliding Ring from the blades by pulling up.

Figure 53

Slide the Tab Breaker over the blades and over theMANTIS Redux screw tabs.

Compression

and Distraction

Construct

Tightening

Tab

Removal

48284070Distractor

48284075Compressor

48289480Counter Torque Tube

48287028Torque Wrench

48289100Tab Breaker

48289077Compression & Distraction Shaft

48289078Compression & Distraction Hinge

48281201Slim Ring

48280081ES2 Torque Wrench

Figure 54

Figure 55

t The Tab Breaker is rocked in a back and forthmotion to break the screw tab.

t The Tab Breaker will retain both the blades andthe screw tab.

30

t The Tab Breaker is removed from the incision.

t Remove the blade and screw tab from the TabBreaker.

t Repeat for all other screws.

Note: The tab breaker has a large window to hold theblade during removal.


Tab

Removal

1 2

Figure 56

Instrument Bar

31

Closure

Examine the site for bleeding.

If accessible, close the fascia with one or two interruptedsutures. The subcutaneous tissue is closed in an invertedmanner. A subcuticular closure is performed. Cover theskin edge with clear waterproof dressing.

Tab

Removal

48289100Tab Breaker

32

Sterile* Reference # Reference # Description

Implant Reference Numbers


Catalog

48289425 48289425S Ø4.5mm x 25mm Polyaxial Reduction Screw






































48289999 48289999S LITe Blocker

*Sterile implants are only available in certain markets outside the U.S. Please contact your Stryker Sales Representativefor more information.

33

Catalog

Implant Reference Numbers

484860(30) – (80) 484860(30) – (80)S Ø6.0 x 30-80mm Hex Rad Rod (5mm increments)

48486(090) – (130) 48486(090) – (130)S Ø6.0 x 90-130mm Hex Rad Rod (10mm increments)

48487(030) – (80) 48487(030) – (80)S Ø6.0 x 30-80mm Hex Straight Rod (5mm increments)

48487(090) – (200) 48487(090) – (200)S Ø6.0 x 90-200mm Hex Straight Rod (10mm increments)

48487480 48487480S Ø6.0 x 480mm Hex Straight Rod

48487600 N/A Ø6.0 x 600mm Hex Straight Rod

Sterile* Reference # Reference # Description

*Sterile implants are only available in certain markets outside the U.S. Please contact your Stryker Sales Representativefor more information.


34

Catalog

Reference # Description

Instrument Part Numbers

48289310 Screwdriver

48289311 Shaft for Polyaxial Screwdriver

48289200 T-Handle Ratchet

48289300 Round Handle Ratchet

48289205 T-Handle Non-Ratchet

48289305 Round Handle Non-Ratchet

48289035 Blade Size 1





48289030 Contouring Shaft

48289100 Tab Breaker

48289480 Counter Torque Tube

48289077 Compression Shaft

48289078 Compression Hinge

48281111 Reduction Helper

48289733 Poly Adjustment Driver

48289001 Tray

48287028 MANTIS Torque Wrench

48280081 ES2 Torque Wrench

48281201 Slim Ring

48281168 8.5mm Modular Tap

35

Indications

Indications and Contraindications

Indications/Intended Use

MANTIS and MANTIS Redux Spinal SystemsThe MANTIS and MANTIS Redux Spinal Systems are intended for percutaneousposterior, noncervical pedicle fixation in skeletally mature patients as an adjunct tofusion for the following indications: degenerative disc disease (DDD) (defined asback pain of discogenic origin with degeneration of the disc confirmed by historyand radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation),spinal stenosis, curvatures (i.e.,scoliosis, kyphosis, and/or lordosis), tumor,pseudoarthrosis and failed previous fusion.

The Ø5.5mm Titanium and VITALLIUM rods from the Stryker Radius SpinalSystem are intended to be used with the other components of MANTIS andMANTIS Redux Spinal Systems.

ContraindicationsContraindications may be relative or absolute. The choice of a particular devicemust be carefully weighed against the patient’s overall evaluation. Circumstanceslisted below may reduce the chances of a successful outcome:

t Any abnormality present which affects the normal process of bone remodelingincluding, but not limited to, severe osteoporosis involving the spine, boneabsorption, osteopenia, primary or metastatic tumors involving the spine, activeinfection at the site or certain metabolic disorders affecting osteogenesis.

t Insufficient quality or quantity of bone which would inhibit rigid device fixation.

t Previous history of infection.

t Excessive local inflammation.

t Open wounds.

t Any neuromuscular deficit which places an unusually heavy load on the deviceduring the healing period.

t Obesity. An overweight or obese patient can produce loads on the spinal systemwhich can lead to failure of the fixation of the device or to failure of the deviceitself.

t Patients having inadequate tissue coverage of the operative site.

t Pregnancy.

t A condition of senility, mental illness, or substance abuse. These conditions,among others, may cause the patient to ignore certain necessary limitations andprecautions in the use of the implant, leading to failure or other complications.

t Foreign body sensitivity. Where material sensitivity is suspected, appropriate testsshould be made prior to material selection or implantation.

t Other medical or surgical conditions which would preclude the potential benefitof spinal implant surgery, such as the presence of tumors, congenitalabnormalities, elevation of sedimentation rate unexplained by other diseases,elevation of white blood cell count (WBC), or marked left shift in the WBCdifferential count. These contraindications can be relative or absolute and must betaken into account by the physician when making his decision. The above list is notexhaustive.


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Indications

General Conditions of UseThe implantation of pedicle screw spinal systems must be performed only byexperienced spinal surgeons having undergone the necessary specific training in theuse of such systems because this is a technically demanding procedure presenting arisk of serious injury to the patient.

The information contained in the Package Insert is necessary but not sufficient for theuse of this device. This information is in no sense intended as a substitute for theprofessional judgment, skill and experience of the surgeon in careful patient selection,preoperative planning and device selection, knowledge of the anatomy andbiomechanics of the spine, understanding of the materials and the mechanicalcharacteristics of the implants used, training and skill in spinal surgery and the use ofassociated instruments for implantation, securing the patient’s cooperation infollowing an appropriately defined post-operative management program andconducting scheduled post-operative follow-up examinations.

Information for PatientsThe surgeon must discuss all physical and psychological limitations inherent to theuse of the device with the patient. This includes the rehabilitation regimen, physicaltherapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion must be directed to the issues of premature weight bearing,activity levels, and the necessity for periodic medical follow-up.

The surgeon must warn the patient of the surgical risks and made aware of possibleadverse effects. The surgeon must warn the patient that the device cannot and doesnot replicate the flexibility, strength, reliability or durability of normal healthy bone,that the implant can break or become damaged as a result of strenuous activity ortrauma, and that the device may need to be replaced in the future. If the patient isinvolved in an occupation or activity which applies inordinate stress upon theimplant (e.g., substantial walking, running, lifting, or muscle strain) the surgeon mustadvise the patient that resultant forces can cause failure of the device. Patients whosmoke have been shown to have an increased incidence of non-unions. Surgeonsmust advise patients of this fact and warn of the potential consequences. For diseasedpatients with degenerative disease, the progression of degenerative disease may be soadvanced at the time of implantation that it may substantially decrease the expecteduseful life of the appliance. In such cases, orthopaedic devices may be considered onlyas a delaying technique or to provide temporary relief.

InfectionTransient bacteremia can occur in daily life. Dental manipulation, endoscopicexamination and other minor surgical procedures have been associated with transientbacteremia. To help prevent infection at the implant site, it is advisable to useantibiotic prophylaxis before and after such procedures.

Implant Selection and UseThe choice of proper shape, size and design of the implant for each patient is crucialto the success of the surgery. The surgeon is responsible for this choice which dependson each patient.

Patients who are overweight may be responsible for additional stresses and strains onthe device which can speed up metal fatigue and/or lead to deformation or failure ofthe implants.

The size and shape of the bone structures determine the size, shape and type of theimplants. Once implanted, the implants are subjected to stresses and strains. These

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Indications

repeated stresses on the implants should be taken into consideration by the surgeon atthe time of the choice of the implant, during implantation as well as in the post-operative follow-up period. Indeed, the stresses and strains on the implants may causemetal fatigue or fracture or deformation of the implants, before the bone graft hasbecome completely consolidated. This may result in further side effects or necessitatethe early removal of the osteosynthesis device.

Improper selection, placement, positioning and fixation of these devices may result inunusual stress conditions reducing the service life of the implant. Contouring orbending of rods or plates is recommended only if necessary according to the surgicaltechnique of each system. Rods or plates should only be contoured with the propercontouring instruments. Incorrectly contoured rods/plates, or rods/plates which havebeen repeatedly or excessively contoured must not be implanted. The surgeon is to bethoroughly familiar with the surgical procedure, instruments and implantcharacteristics prior to performing surgery. Refer to the Stryker Spine surgicalprotocols for additional procedural information. Periodic follow-up is recommendedto monitor the position and state of the implants, as well as the condition of theadjoining bone.

Post-Operative CarePrior to adequate maturation of the fusion mass, implanted spinal instrumentationmay need additional help to accommodate full load bearing. External support may berecommended by the physician from two to four months postoperatively or until x-rays or other procedures confirm adequate maturation of the fusion mass; externalimmobilization by bracing or casting be employed. Surgeons must instruct patientsregarding appropriate and restricted activities during consolidation and maturationfor the fusion mass in order to prevent placing excessive stress on the implants whichmay lead to fixation or implant failure and accompanying clinical problems. Surgeonsmust instruct patients to report any unusual changes of the operative site to his/herphysician. The physician should closely monitor the patient if a change at the site hasbeen detected.

Adverse Effectst While the expected life of spinal implant components is difficult to estimate, it is

finite. These components are made of foreign materials which are placed withinthe body for the potential fusion of the spine and reduction of pain. However, dueto the many biological, mechanical and physicochemical factors which affect thesedevices but cannot be evaluated in vivo, the components cannot be expected toindefinitely withstand the activity level and loads of normal healthy bone.

t Bending, disassembly or fracture of any or all implant components.

t Fatigue fracture of spinal fixation devices, including screws and rods, has occurred.

t Pain, discomfort, or abnormal sensations due to the presence of the device.

t Pressure on skin from components where inadequate tissue coverage exists overthe implant, with the potential extrusion through the skin.

t Dural leak requiring surgical repair.

t Loss of proper spinal curvature, correction, height and/or reduction.

t Delayed Union or Nonunion: Internal fixation appliances are load sharing deviceswhich are used to obtain alignment until normal healing occurs. In the event thathealing is delayed, does not occur, or failure to immobilize the delayed/nonunionresults, the implant will be subject to excessive and repeated stresses which caneventually cause loosening, bending or fatigue fracture. The degree or success ofunion, loads produced by weight bearing, and activity levels will, among otherconditions, dictate the longevity of the implant. If a nonunion develops or if the


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Indications

implants loosen, bend or break, the device(s) should be revised or removedimmediately before serious injury occurs.

t Loosening of spinal fixation implants can occur. Early mechanical loosening mayresult from inadequate initial fixation, latent infection, premature loading of theprosthesis or trauma. Late loosening may result from trauma, infection, biologicalcomplications or mechanical problems, with the subsequent possibility of boneerosion, migration and/or pain.

t Peripheral neuropathies, nerve damage, heterotopic bone formation andneurovascular compromise, including paralysis, loss of bowel or bladder function,or foot-drop may occur.

t Serious complications may be associated with any spinal surgery. Thesecomplications include, but are not limited to: genitourinary disorders;gastrointestinal disorders; vascular disorders, including thrombus;bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardialinfarction, infection, paralysis or death.

t Neurological, vascular, or soft tissue damage due directly to the unstable nature ofthe fracture, or to surgical trauma.

t Inappropriate or improper surgical placement of this device may cause distractionor stress shielding of the graft or fusion mass. This may contribute to failure of anadequate fusion mass to form.

t Decrease in bone density due to stress shielding.

t Intraoperative fissure, fracture, or perforation of the spine can occur due toimplantation of the components. Postoperative fracture of bone graft, theintervertebral body, pedicle, and/or sacrum above and/or below the level of surgerycan occur due to trauma, the presence of defects, or poor bone stock.

Adverse effects may necessitate reoperation or revision.

Removal of ImplantsThese implants are temporary internal fixation devices designed to stabilize theoperative site during the normal healing process. After healing occurs, these devicesserve no functional purpose and can be removed. Removal may also berecommended in other cases, such as:

t Corrosion with a painful reaction

t Migration of the implant, with subsequent pain and/or neurological, articular orsoft tissue lesions

t Pain or abnormal sensations due to the presence of the implants

t Infection or inflammatory reactions

t Reduction in bone density due to the different distribution of mechanical andphysiological stresses and strains

t Failure or mobilization of the implant

Standard ancillaries provided by Stryker Spine can be used to remove the implants.Any decision by a physician to remove the internal fixation device must take intoconsideration such factors as the risk to the patient of the additional surgicalprocedure as well as the difficulty of removal. Removal of an unloosened spinal screwmay require the use of special instruments to disrupt the interface at the implantsurface. This technique may require practice in the laboratory before being attemptedclinically. Implant removal should be followed by adequate postoperativemanagement to avoid fracture or re-fracture. Removal of the implant after fracturehealing is recommended. Metallic implants can loosen, bend, fracture, corrode,migrate, cause pain or stress shield bone.

Pre-operative PrecautionsAnyone using Stryker Spine products can obtain a Surgical Technique brochure byrequesting one from a distributor or from Stryker Spine directly. Those usingbrochures published more than two years before the surgical intervention are advisedto get an updated version.

Stryker Spine devices can only be used by doctors who are fully familiar with thesurgical technique required and who have been trained to this end. The doctoroperating must take care not to use the instruments to exert inappropriate stress onthe spine or the implants and must scrupulously comply with any operatingprocedure described in the surgical technique provided by Stryker Spine. Forexample, the forces exerted when repositioning an instrument in-situ must not beexcessive as this is likely to causes injury to the patient.

To reduce the risks of breakage, care must be taken not to distort the implants ornick, hit or score them with the instruments unless otherwise specified by theapplicable Stryker Spine Surgical Technique.

Extreme care must be taken when the instruments are used near vital organs, nervesor vessels.

Unless otherwise specified on the label, the instruments can be reused afterdecontamination, cleaning and sterilization.

CautionFederal law (U.S.A) restricts this device to sale by or on the order of a licensedphysician.

Warning (U.S.A.)The safety and effectiveness of pedicle screw spinal systems have been established onlyfor spinal conditions with significant mechanical instability or deformity requiringfusion with instrumentation. These conditions are significant mechanical instabilityor deformity of the thoracic, lumbar, and sacral spine secondary to spondylolisthesis(grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objectiveevidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinaltumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness ofthese devices for any other conditions are unknown.

The MANTIS Spinal System has not been tested for heating or migration in the MRenvironment.

Precautions (U.S.A.)The implantation of pedicle screw spinal systems should be performed only byexperienced spinal surgeons with specific training in the use of this pedicle screwspinal system because this is a technically demanding procedure presenting a risk ofserious injury to the patient.

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Indications

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particularproduct when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeonsbe trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must alwaysrefer to the package insert, product label and/or instructions for use before using any Stryker product. Products maynot be available in all markets because product availability is subject to the regulatory and/or medical practices inindividual markets. Please contact your Stryker representative if you have questions about the availability of Strykerproducts in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarks or service marks: ES2, LITe, MANTIS, Radius, Stryker, Vitallium, Xia. All other trademarks are trademarksof their respective owners or holders.

MIRDX-ST-3_Rev-2SC/GS 11/15

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Stryker Spine2 Pearl Court Allendale, NJ 07401-1677 USAt: 201-760-8000www.stryker.com

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