Surgical Technique Guide - Zimmer Biomet€¦ · spinal stenosis and trauma. 2 ... instrumentation techniques. SURGICAL EXPOSURE AND SITE PREPARATION • Patient positioning is critical

Surgical Technique Guide

The following general Surgical Technique Guide is for illustrative purposes only. As with all surgical procedures, the technique used in each case will depend on the surgeon’s medical judgment as to the best treatment for each patient. Detailed preoperative clinical and diagnostic evaluation followed by carefully executed surgical technique is essential. Only those individuals with specialized training and experience in spinal surgery should attempt to use the Silverton Spinal Fixation and Silverton-D Deformity Systems. Refer to the Instructions for Use for a more complete description of indications, contraindications, warnings, cautions and other information about the system.

The Silverton® Spinal Fixation System combined with the Silverton-D® Deformity System supports the surgical correction of various spinal deformities, including scoliosis, in addition to the treatment of various conditions such as degenerative disc disease, spinal stenosis and trauma.

2 BIOMET SPINE

The Silverton® Spinal Fixation System combined with the Silverton-D® Deformity System supports the surgical correction of various spinal deformities, including scoliosis, in addition to the treatment of various conditions such as degenerative disc disease, spinal stenosis and trauma. The selection of pedicle screws, rods, connectors and hooks provides temporary vertebral stabilization of spinal segments in the thoracic, lumbar and sacral regions during spinal fusion.

The systems are surgeon-guided to incorporate unique and critical features while providing versatility, excellent construct strength and intuitive instrumentation.

FEATURES: •Lowprofile:providesminimaltissueirritation

•Toploading/toptightening:conservestissue,whilesimplifyingconstructassembly

•Anti-splayreversebuttressthread:convertstorqueintogrippingforcewithoutheadsplay

•Screwthreaddesign:constantouterdiameterwithtaperedminordiameterprovidesmaximumpurchaseofcorticalandcancellousbone

•Lockingmechanism:designedtomaximizeforceperunitareaforunparalleledlockingstrength

•Simple,intuitiveinstrumentation:instrumentsarewellthoughtoutandthetraysarearrangedinsequenceofuse

•Crossconnectorjaws:contouredtominimizenotchingoftherod

•Multiplerodtypes:straightandpre-bentrodswiththreedifferentmaterialoptions

•Specializedimplants:allowforintaroperativeversatility

SILVERTON® SPINAL FIXATION SYSTEM SURGICAL TECHNIQUE GUIDE 3

Figure1 Patient positioning

PREOPERATIVE PREPARATION•Reviewandinspectallinstrumentationandimplants

priortosterilization.

•Implantsandinstrumentsareprovidednon-sterileandmustbecleanedandsterilizedpriortouse.

•Replaceoraddanyneededcomponentsfortheplannedsurgery.

•Primarysurgeonmustbefullyexperiencedwiththerequiredposterior,occipito-cervico-thoracicinstrumentationtechniques.

SURGICAL EXPOSURE AND SITE PREPARATION•Patientpositioningiscriticalforoccipito-cervical

fusionprocedures.

•Thepatientshouldbeplacedontheoperatingtableinthepronepositionwiththepatient’sheadsecurelyimmobilized.

•Beforedraping,confirmproperpatientpositionbydirectvisualizationandbyradiograph.

•Alwaysusecautionwhenpositioningthepatient,asphysiologicalalignmentmaynotbeattainable.

•Performastandardmidlinesubperiostealexposureoftheportionofthecervico-thoracicspinetobefused.

•Completeawideexposureextendingtothelateralaspectofthefacetjointsinthecervicalspineandthetransverseprocessesinthethoracicspine.

•Extendtheexposuretotheexternaloccipitalprotuberanceifthefusionwillincludetheocciput.

•Bemindfulofavoidinginjurytothevertebralarteries,spinalcordandC2nerverootsintheuppercervicalspine.Caremustalsobetakentoavoidthefacetcapsulesandinterspinousligamentsatlevelsthatwillnotbefused.

4 BIOMET SPINE

1. •Theawl isusedtopenetratetheoutercortexofthepedicleand

cannotbeinsertedbeyond10mm(Figure 1).

2. •Eitherthestraight pedicle probe orthecurved pedicle probe

canbeusedtolocalizethepedicleandopenapathway.Correctrotationalinsertionoftheinstrumentwillallowtheprobetofollowapathofleastresistancewithoutviolatingthepediclewalls.Thepedicleprobesarelasermarkedat10mmintervalstodisplaydepthandaidinappropriatescrewlengthselection(Figure 2).

3. •Thestraight sounder andcurved sounder areball-tippedfeeler

probesdesignedtoassistthesurgeoninassessingtheintegrityofthepediclewallsandanteriorcortexafteruseofthepedicleprobes.Thesoundersalsoincludedepthmarkingsat10mmintervals(Figure 3).

4. •Tapsmaybeused,althoughtheSilverton®pediclescrews

areself-tapping.Tapsaresizedexactlyasthecorrespondingpediclescrew,thereforeundertappingmaybedesired.Tapsareavailableinfourdiameters(4.5mm, 5.5mm,6.5mmand7.5mm)andmaybeattachedtoeithertheratcheting straight handleorT-handle.Thetapsarelasermarkedinthesamemannerastheprobesandsounders.Tapthreadlengthis30mm(Figure 4).

PEDICLE SCREW PREPARATION

Figure1

Figure2

Figure3

Figure 4


5. •Thepediclescrewsareinsertedwiththebone screw driver

whichisattachedtoeithertheratchetingstraighthandleorT-handle.Thestrawisaslipsleevethataidsinpreventinginadvertentdisengagementofthescrewduringinsertion.

•Thebonescrewdriverconsistsof3 elements:

a.bone screw driver shaft

b.bone screw driver sleeve

c.bone screw driver straw

6. •Whenloadingascrewontothebonescrewdriver:

a.Drawthesleevewiththestrawupwardtowardthehandle.

b.Orienttheprongswiththescrewheadslotsandinsert.

c.Withtheprongsproperlyseated,thesleeveassemblyis threadedintothescrewheadbyrotatingclockwise.

Note: The prongs of the screw driver tip need to align and engage into the corresponding screw head slots. It is helpful to gently rotate the screw shaft until the prongs are seated into the grooves on the head of the screw shaft. If the screw driver prongs are not seated, the screw cannot be loaded.

7. •Theratchetinghandleshouldbesetforproperrotationdirection

(clockwiseorneutralforinsertion).Thisisaccomplishedbyrotatingthemetalcollaronthehandle.

BONE SCREW DRIVER SHAFT

BONE SCREW DRIVER SLEEVE

BONE SCREW DRIVER STRAW

SCREW LOADING

PEDICLE SCREW INSERTION

6 BIOMET SPINE

8. •Oncethedesiredinsertiondepthisachieved,thescrew

canbedisengagedfromthescrewdriver(Figure 5).

a.Graspandmaintainthepositionoftheratchethandle/ screwdrivershaftassembly.

b.Unthreadthesleevefromthescrewheadandremove.

c.Confirmappropriateimplantlocationradiographically.

Note: For subsequent screw removal or height adjustment, the screw loading sequence must be used. Do not attempt to turn the screw without having the sleeve threaded into the screw head, as this may cause the driver tips to be damaged.

9. •Thepolyaxialscrewheadmaybepositionedandalignedusing

thebone screw driver/head turner (Figure 6).

SCREW HEAD ADJUSTMENT

Figure 5

Figure 6

PEDICLE SCREW INSERTION (CONTINUED)


10. •TheSilvertonSpinalFixationSystemincludespre-bentrodsin

10mmincrementsanda400mmstraightrod.IntheSilverton-DDeformitySystem,rigid(Ti-6Al-4V),cobaltchrome(CoCrMo),andmalleablerods(CpTi)areincludedwithahexagonalendforrodrotationifrequired.Forrodbending/contouring,a french rod bender orin situ rod bendersmaybeutilized.

11. •Usingtherod inserter,placetheselectedrodintothescrew

heads.Foradditionalrodinsertionorasanalternative,therod holder maybeused.Provisionalsetscrewtighteningmaybeneededtostabilizetherod(Figure 8).

12. •Additionalrodmanipulationmaybeneededforsetscrew

placement;therod pusher orset screw guide maybeusedtoestablishthedirectaxialpathwaytothescrewheadforsetscrewplacement.Thesetscrewguidehasaslightlylargerdistalendthatisplacedoverthescrewheadandrod.Withdownwardpressure,pushtherodintotheproperpositionofthescrewheadandintroducethesetscrewdownthecannulatedshaft(Figure 9).

ROD CONTOURING

ROD PLACEMENT

Once all the screws are placed, an approximately sized rod may be chosen. 500mm rod templates are available in both the Silverton® and Silverton-D® Deformity spinal fixation system surgical cases (Figure 7).

Figure 7

Figure 8

Figure 9

8 BIOMET SPINE

13. •Therod rockermaybeusedtointroducetherodintothescrew

headwiththeuseofaleveringaction(Figure 10).

14. •Therod persuader generatessignificantforcetoapproximate

thescrewheadandrod.Ensurethattheratchetmechanismisfullydisengagedandplacethearmsintothegroovesonbothsidesofthescrewhead.Re-engagetheratchetandgraduallysqueezethepistolgripuntilratchetingstops.Introducethesetscrewdownthecannulatedshaftandprovisionallytighten.Todisengagetheinstrumentfromthescrew,releasetheratchetlockandrotatetheinstrument90degrees(Figure 11).

•Oncetherodisfullyseated,theremainingsetscrewsmaybeplacedtosecuretherod.

SET SCREW PLACEMENT

Figure 10

Figure 11


15. •Theset screw starter isaself-retainingdouble-ended

instrumentdesignedforinitialthreadingandprovisionaltighteningofthesetscrews.Caremustbetakentoavoidhightorques,asthismaydamagetheinstrumenttip.

Note: The reverse buttress thread design of the set screw requires the set screw to be oriented correctly prior to insertion. If it is loaded onto the set screw starter upside down, it will not engage the screw head. Insert the starter or driver into the set screw such that the gold side of the set screw is facing up.

Tip: It is helpful to begin the set screw engagement by rotating the set screw counterclockwise. No more than a one-half turn should be required. During the counterclockwise rotation, a tactile click will indicate that the lead thread is in ideal position to engage. Once the click is felt, the clockwise tightening direction should be started (Figure 12).

•AdditionalCorrectiveManeuvers:WheninsertingtheSilverton-D®malleable,rigidorcobaltchromerods,manipulationoftherodandpediclescrewheadangulationscanbeachievedwhenusingthederotation wrench ontherodhexagonalendandusingthederotation tube onthepediclescrewhead.

Figure 12

10 BIOMET SPINE

16. •Oncetherodhasbeenfullyseatedintoallofthepolyaxial

screwheadsandthesetscrewsareinplace,distractionorcompressionmaybeaccomplishedusingeitherthedistractor orthecompressor(Figure 13a,b).

17.FINAL TIGHTENING •Finaltighteningisperformedusingthefollowingthree

instruments:counter torque,torque limiting handle andthe set screw tightener.

•Attachthe(a)torquelimitinghandletothe(b)setscrewtightenerandinsertintothe(c)countertorqueinstrument.

18. •Whileretractingthecountertorquetovisualizefullengagement

ofthesetscrew,placethetipofthesetscrewtightenerintothesetscrewforfinaltightening(Figure 14).

19. •Lowerthecountertorqueoverthescrewheadwhileengaging

therod.Thenrotatethetorquelimitinghandleclockwiseuntilasnapisheard.Finaltighteningisaccomplishedat80in-lb(9.0Nm)(Figure 15).

COMPRESSION AND DISTRACTION

(a) TORQUE LIMITING HANDLE

(b) SET SCREW TIGHTENER

(c) COUNTER TORQUE INSTRUMENT

Figure 13a

Figure 13b

Figure 14

Figure 15


20.CROSS CONNECTORS •Forinitialplacementormanualtighteningofthecross

connectortotherods,usetheset screw driver shaft cross connector.Backoutthesetscrewsenoughtoallowthejawstoadequatelyencompasstherods(Figure 16).

Note: Fixed and variable cross connectors are available. The fixed version comes in specific lengths for use in situations where rods are parallel; the variable cross connectors can accommodate rods from 40–80mm apart (See page 22).

21. •Oncethejawshavecapturedtherods,tightenthesetscrews

(Figure 17).

•Provisionaltighteningofthevariablecrossconnectorcanbeachievedviathecentralnutusingthenut driver shaft cross connector.

22. •Finaltighteningofthecrossconnectorisachievedbyusing

thetorque limiting handle 40 in-lb (4.5Nm)inconjunctionwiththeset screw driver shaft cross connectorforconnectiontotherodsandthenut driver shaft cross connectorforthecentralnutonthevariablecrossconnector.

Note: If needed, the cross connector bender may be used. Prior to bending a variable cross connector, set the length as needed and provisionally tighten the central nut.

Figure 17

Figure 16

12 BIOMET SPINE

MONOAXIAL SCREWS •Monoaxialscrewsarecolorcodeddependingonthescrew

diameter.Variousconfigurationsofscrewdiameterandlengthareavailable,rangingfrom4.5–8.5mmscrewdiameterswithscrewlengthsof25–100mm.Afterthepediclesareprepared(asexplainedearlier),themonoaxialscrewisplacedusingthemono bone screw driver,bone screw driver sleeveandthebone screw driver straw.

COMPRESSION AND DISTRACTION (CONTINUED)

BONE SCREW DRIVER STRAW


MONO BONE SCREW DRIVER

MONOAXIAL SCREW DRIVER ENGAGEMENT

MONOAXIAL SCREWS


REDUCTION SCREWS •Ifrequired,theSilverton-D®reductionscrewsareavailablefor

rodreductionorreductionofspondylolisthesis.Silverton-Dreductionscrewsareavailablein5.5mm,6.5mmand7.5mmscrewdiameterswith35mm,40mm,45mmand 50mmscrewlengths.Afterthepediclesareprepared(asexplainedearlier),thereductionscrewsareplacedusingthereduction screw driver shaft,bone screw driver sleeve,andthereduction strawconnectedtotheratcheting straight handleorT-handle.

•Ifneeded,therodreductiontechniqueslistedabovemaybeusedtoapproximatetherodwithinthetuliphead.Toassistinsetscrewalignmentwiththethreadsintheheadofthereductionscrew,theanti-splay ringorthereduction strawcanbeappliedandprovisionaltighteningcompleted(Figure 18a,b).

•Theextendedportionofthereductionscrewcannowberemovedusingthereduction screw pliers.Thisisaccomplishedbyslidingthereductionscrewpliersovereachextendedtabofthescrewheadandleveragingfirstinamedialthenlateraldirectiontoavoidpossiblescrewheadsplay.Themedial,lateralactionmayneedtoberepeatedseveraltimesuntileachtabisbrokenoff.Finalsetscrewtighteningcanbeperformedusingthereduction counter torque inconjunctionwiththesetscrewtightenerandthetorquelimitinghandle,whichissetatatorqueof80in-lb(9.0Nm).


REDUCTION STRAW

REDUCTION SCREW TAB REMOVAL REDUCTION SCREW DRIVER ENGAGEMENT

REDUCTION BONE SCREW DRIVER SHAFT

Figure 18a

Figure 18b

14 BIOMET SPINE

HOOK INSERTION

23. •LaminarHooks:Thelaminaispreparedwiththelamina hook

finder.Asmallosteotomemaybeneededtopreparethelaminaforthehook,andtheligamentumflavummustbescrapedofftheundersideofthelamina.Thiswillallowatightandsecurefitofthehook.Thelaminarhookfinderisusedtodeterminetheappropriatehooksizeandlocationinpreparationofhookplacement(Figure 19).

Note: Extended body, ramped blade, angled blade, angled and offset hooks are placed using the same technique as with the laminar hooks.

•Attachtheselectedhooktoeitherthestraight orlateral hook holder.Thehookisinsertedinadownwardrotationalmotion,allowingthebladetiptohugtheundersideofthelamina.Thehook pusher maybeusedtohelpguideandseatthehookagainstthelamina.

24. •PedicleHooks:Alwaysdirectedinthecephaladdirection,the

pediclehooksareplacedintothefacetjointwiththebifidtipagainstthepedicle.Thepedicle hook finder isusedtoidentifythepedicleandprepareasiteforthehooktoevenlyseatontothepedicle.Pediclehooksareinsertedusingeitherthestraightorlateralhookholder(Figure 20).

•Finaltighteninginstrumentationisexplainedonpage10.

HOOKS

Thirteen hook configurations are available in various sizes and angulations, depending on the position and placement in the non-cervical spine (see page 23 for hook styles). After appropriate dissection and anatomic levels are verified, the hook sites can be prepared and appropriate hooks selected.

Figure 19

Figure 20


25. •Aftertheoffsetconnectorhasbeenselectedandpositioned,

setscrewtighteningiscomplete(Figure 21).

a.Openoffsetconnectorsusethestandard set screws. Finaltighteningisperformedusingthefollowing instruments:countertorque,torquelimitinghandle andthesetscrewtightener.

b.Closedoffsetconnectorsusethesmall set screws.Final tighteningisperformedusingthefollowinginstruments: small set screw tightener gold tip andtorquelimitinghandle 40 in-lb(4.5Nm).

Offset connectors allow medial and lateral variability when connecting screws to a rod. This may be useful when attempting to capture the rod between screws and hooks. Closed offset connectors may be pre-loaded on the rod prior to placement into the screw or hook head. The small set screws are used for this connection. The regular set screws are used to tighten the open offset connectors to the rod.

Offset connectors are offered in three open lengths: 15mm, 25mm and 40mm. There is also one closed offset connector with a length of 40mm.

OFFSET CONNECTORS

Figure 21

16 BIOMET SPINE

PARALLEL CONNECTOR, 2X2

PARALLEL CONNECTOR, 1X2

PARALLEL CONNECTOR, EXTENDED BODY 1X2

PARALLEL CONNECTOR, EXTENDED BODY 2X2

AXIAL CONNECTOR

ROD TO ROD CONNECTORS

Parallel and axial connectors are used to either increase the length or approximate two independent rods by joining them together.

There are four different configurations of parallel connectors and one axial connector.

26. •Aftertherod-to-rodconnectorhasbeenselectedandpositioned,

setscrewtighteningiscompletedusingthefollowinginstruments:smallsetscrewtightenergoldtipandtorquelimitinghandle, 40 in-lb(4.5Nm).

Note: For tightening of the special order items (parallel connector open and parallel connector extended body open), the set screws are tightened using the set screw tightener short.


CLOSURE

REMOVING THE SILVERTON® SPINAL FIXATION SYSTEM (IF NECESSARY)

1.Deteriorationofthedeviceafterboneconsolidationcannotbeconsideredtoconstituteadysfunctionordeteriorationinthecharacteristicsoftheimplant.Theimplantcanberemovedaftertheconsolidationofthebonegraft.

2.Ifanonuniondevelopsorifthecomponentsloosen,bend,and/orbreak,reviseand/orremovethedevice(s)immediatelybeforeseriousinjuryoccurs.Failuretoimmobilizeadelayednonunionofbonewillresultinexcessiveandrepeatedstressesontheimplant.Bythemechanismoffatigue,thesestressescancauseeventualbending,looseningorbreakageofthedevice(s).

3.Theimplantmayberemovedafterhealing.Particularlyinyoungactivepatients,implantsmayloosen,fracture,corrode,migrate,andincreasetheriskofinfection,causepain,orstresstheshieldbone–evenafternormalhealing.Thesurgeonmustconsidertherisksandbenefitswhendecidingwhetherornottoremoveanimplant.Implantremovalmustbefollowedbycarefulpostoperativemanagementtoavoidre-fracture.Ifthepatientisolderandhasalowactivitylevel,thesurgeonmayelectnottoremovetheimplantinordertoeliminatetherisksofanothersurgery.

4.Neverreuseexplantedsurgicalimplants.

5.Standardsetscrewremovalmaybeaccomplishedusingcountertorque,thesetscrewtightenerandtheT-handlefixed.Whenallofthesetscrewshavebeenremoved,therodmayberemovedusingtherodinserterortherodholder.Thetorquelimitinghandleshouldneverbeusedtoremovesetscrews.

6.Polyaxialpediclescrewremovalmaybeaccomplishedusingthebonescrewdriver.Inordertoensureatightfitbetweenthescrewandthescrewdriver,itisrecommendedthatallthreescrewdrivercomponentsareusedwhenremovingpediclescrews(shaft,sleeve,straw).Itmaybenecessarytorotatetheheadoftheimplantedscrewtoallowtheprongsoftheshafttoalignwithandengagetheslotsontheheadofthescrewshaft.

6.Monoaxialscrewsmayberemovedusingthemonoaxialbonescrewdriverinadditiontotheoutersleeveandstraw.

27. •Closewoundanddressintheusualfashion.

18 BIOMET SPINE

SILVERTON® INSTRUMENTS

Bone Awl Trocar Point • 7704-1001

Straight Handle Ratcheting • 7704-1030

T-Handle Ratcheting • 7704-1031

Rod Template • 7704-1067

Bone Screw Driver/Head Turner Monoaxial • 7704-1046

Rod Inserter 5.5mm • 7704-1041

Rod Holder • 7704-1042

Rod Rocker • 7704-1090

Rod Pusher 5.5mm Rod • 7704-1092

Pedicle Bone Probe Straight 3.7mm • 7704-1002

Pedicle Bone Probe Curved 3.7mm • 7704-1003

Sounder Straight • 7704-1004

Sounder Curved • 7704-1006

Tap 4.5mm • 7704-1024

Tap 5.5mm • 7704-1025

Tap 6.5mm • 7704-1026

Tap 7.5mm • 7704-1027

Bone Screw Driver Shaft • 7704-1235

Bone Screw Driver Sleeve • 7704-1035

Bone Screw Driver Straw • 7704-1035-003


T-Handle Fixed • 9803-0001

Rod Persuader • 7704-1095

Set Screw Starter • 7704-1037

In Situ Rod Benders Left & Right Set • 7704-1060

French Rod Bender • 7704-1065

Distractor • 7704-1070

Compressor 65mm • 7704-1076

Torque Limiting T-Handle • 7704-1181 Non-Cannulated

Counter Torque • 7704-1285

Set Screw Guide Shaft • 7704-1036Set Screw Tightener Short • 7706-1139

Table Top Rotary Rod Cutter • 7704-1066

Cross Connector Bender • 7705-1060

Set Screw Driver Shaft Cross Connector • 7705-1110

Nut Driver Shaft Cross Connector • 7705-1120

Cross Connector Sizing Card • 7704-1201

Torque Limiting Handle 40 in-lb • 7704-1240

20 BIOMET SPINE

SILVERTON-D® INSTRUMENTS

Laminar Hook Finder • 7704-3011

Pedicle Hook Finder Narrow • 7704-3013

Pedicle Hook Finder TP Large • 7704-3014

Straight Hook Holder • 7704-3020

Lateral Hook Holder • 7704-3021

Hook Pusher • 7704-3030

Reduction Counter Torque • 7704-1086

Reduction Bone Screw Driver Shaft • 7704-1935

Reduction Screw Driver Straw • 7704-1936

Monoaxial Bone Screw Driver Shaft • 7704-1147

Set Screw Tightener • 7704-1138

Rod Template, 500mm • 7704-3050

Small Set Screw Tightener, Gold Tip • 7704-3138

Wrench Derotation • 7704-3041

Derotation Tube Deformity • 7704-3036

Reduction Screw Pliers • 7704-3019

Anti-Splay Ring • 7704-1937


SILVERTON® IMPLANTS

Polyaxial Pedicle Screws

Part # Diameter Length

7715-4525* 4.5mm 25mm

7715-4530* 4.5mm 30mm

7715-4535* 4.5mm 35mm

7715-4540* 4.5mm 40mm

7715-4545* 4.5mm 45mm

7715-5530 5.5mm 30mm

7715-5535 5.5mm 35mm

7715-5540 5.5mm 40mm

7715-5545 5.5mm 45mm

7715-5550 5.5mm 50mm

7715-6530 6.5mm 30mm

7715-6535 6.5mm 35mm

7715-6540 6.5mm 40mm

7715-6545 6.5mm 45mm

7715-6550 6.5mm 50mm

7715-6555 6.5mm 55mm

7715-7530 7.5mm 30mm

7715-7535 7.5mm 35mm

7715-7540 7.5mm 40mm

7715-7545 7.5mm 45mm

7715-7550 7.5mm 50mm

7715-7555 7.5mm 55mm

Titanium Straight Rods, Pre-Cut


7701-0030 5.5mm 30mm

7701-0035 5.5mm 35mm

7701-0040 5.5mm 40mm

7701-0045 5.5mm 45mm

7701-0050 5.5mm 50mm

7701-0055 5.5mm 55mm

7701-0060 5.5mm 60mm

7701-0065 5.5mm 65mm

7701-0070 5.5mm 70mm

7701-0075 5.5mm 75mm

7701-0080 5.5mm 80mm

7701-0090 5.5mm 90mm

7701-0100 5.5mm 100mm

7701-0110 5.5mm 110mm

7701-0120 5.5mm 120mm

7701-0400 5.5mm 400mm

7701-0500 Rigid 500mm w/ Hex Tips

7701-2500 Malleable 500mm w/ Hex Tips

Titanium Curved Rods, Pre-Cut


7701-1030 5.5mm 30mm

7701-1035 5.5mm 35mm

7701-1040 5.5mm 40mm

7701-1045 5.5mm 45mm

7701-1050 5.5mm 50mm

7701-1055 5.5mm 55mm

7701-1060 5.5mm 60mm

7701-1065 5.5mm 65mm

7701-1070 5.5mm 70mm

7701-1075 5.5mm 75mm

7701-1080 5.5mm 80mm

7701-1085 5.5mm 85mm

7701-1090 5.5mm 90mm

7701-1095 5.5mm 95mm

7701-1100 5.5mm 100mm

7701-1105 5.5mm 105mm

7701-1110 5.5mm 110mm

22 BIOMET SPINE

SILVERTON® IMPLANTS

Polyaxial Pedicle Screws Auxiliary Tray


7715-6560 6.5mm 60mm

7715-6570 6.5mm 70mm

7715-6580 6.5mm 80mm

7715-7560 7.5mm 60mm

7715-7570 7.5mm 70mm

7715-7580 7.5mm 80mm

7715-8535 8.5mm 35mm

7715-8540 8.5mm 40mm 7715-8545 8.5mm 45mm 7715-8550 8.5mm 50mm 7715-8555 8.5mm 55mm

7715-8560 8.5mm 60mm

7715-8570 8.5mm 70mm

Variable Cross Connectors

Part # Length

7702-1040 40–45mm

7702-1045 43–50mm

7702-1050 48–60mm

7702-1060 58–80mm

Fixed Cross Connectors

Part # Length

7702-1128 28mm

7702-1131 31mm

7702-1134 34mm

7702-1137 37mm

7702-1140 40mm


Hooks

Part # Description Part # Description

7720-0508 Hook, Laminar, Narrow Blade, Small

7720-0510 Hook, Laminar, Narrow Blade, Large

7720-0708 Hook, Laminar, Wide Blade, Small

7720-0710 Hook, Laminar, Wide Blade, Large

7721-0707 Hook, Pedicle, Small

7721-0909 Hook, Pedicle, Large

7722-0509 Hook, Extended Body

Monoaxial Pedicle Screws

Part # Diameter Length Part # Diameter Length

7717-4525 4.5mm 25mm

7717-4530 4.5mm 30mm

7717-4535 4.5mm 35mm

7717-4540 4.5mm 40mm

7717-4545 4.5mm 45mm

7717-5530 5.5mm 30mm

7717-5535 5.5mm 35mm

7717-5540 5.5mm 40mm

7717-5545 5.5mm 45mm

7717-5550 5.5mm 50mm

7717-6530 6.5mm 30mm

7717-6535 6.5mm 35mm

7717-6540 6.5mm 40mm

7717-6545 6.5mm 45mm

7717-6550 6.5mm 50mm

7717-6555 6.5mm 55mm

7717-6560 6.5mm 60mm

7717-6570 6.5mm 70mm

7717-6580 6.5mm 80mm

7717-7540 7.5mm 40mm

7717-7545 7.5mm 45mm

7717-7550 7.5mm 50mm

7717-7555 7.5mm 55mm

7717-7560 7.5mm 60mm

7717-7570 7.5mm 70mm

7717-7580 7.5mm 80mm

7717-8530 8.5mm 30mm

7717-8535 8.5mm 35mm

7717-8540 8.5mm 40mm

7717-8545 8.5mm 45mm

7717-8550 8.5mm 50mm

7717-8555 8.5mm 55mm

7717-8560 8.5mm 60mm

7717-8570 8.5mm 70mm

7717-8580 8.5mm 80mm

7717-8590 8.5mm 90mm

7717-8500 8.5mm 100mm

SILVERTON-D® IMPLANTS

7723-0508 Hook, Ramped Blade

7724-0510 Hook, Angled Blade

7725-3507 Hook, Angled, Left

7725-4507 Hook, Angled, Right

7726-3509 Hook, Offset, Left

7726-4509 Hook, Offset, Right

24 BIOMET SPINE

SILVERTON-D® IMPLANTS (CONTINUED)

Polyaxial Reduction Pedicle Screws

Part # Diameter Length Part # Diameter Length Part # Diameter Length

7709-4525 4.5mm 25mm

7709-4530 4.5mm 30mm

7709-4535 4.5mm 35mm

7709-4540 4.5mm 40mm

7709-4545 4.5mm 45mm

7709-4550 4.5mm 50mm

7709-4555 4.5mm 55mm

7709-4560 4.5mm 60mm

7709-4565 4.5mm 65mm

7709-4570 4.5mm 70mm

7709-4575 4.5mm 75mm

7709-4580 4.5mm 80mm

7709-4585 4.5mm 85mm

7709-4590 4.5mm 90mm

7709-4595 4.5mm 95mm

7709-4500 4.5mm 100mm

7709-5525 5.5mm 25mm

7709-5530 5.5mm 30mm

7709-5535 5.5mm 35mm

7709-5540 5.5mm 40mm

7709-5545 5.5mm 45mm

7709-5550 5.5mm 50mm

7709-5555 5.5mm 55mm

7709-5560 5.5mm 60mm

7709-5565 5.5mm 65mm

7709-5570 5.5mm 70mm

7709-5575 5.5mm 75mm

7709-5580 5.5mm 80mm

7709-5585 5.5mm 85mm

7709-5590 5.5mm 90mm

7709-5595 5.5mm 95mm

7709-5500 5.5mm 100mm

7709-6525 6.5mm 25mm

7709-6530 6.5mm 30mm

7709-6535 6.5mm 35mm

7709-6540 6.5mm 40mm

7709-6545 6.5mm 45mm

7709-6550 6.5mm 50mm

7709-6555 6.5mm 55mm

7709-6560 6.5mm 60mm

7709-6565 6.5mm 65mm

7709-6570 6.5mm 70mm

7709-6575 6.5mm 75mm

7709-6580 6.5mm 80mm

7709-6585 6.5mm 85mm

7709-6590 6.5mm 90mm

7709-6595 6.5mm 95mm

7709-6500 6.5mm 100mm

7709-7525 7.5mm 25mm

7709-7530 7.5mm 30mm

7709-7535 7.5mm 35mm

7709-7540 7.5mm 40mm

7709-7545 7.5mm 45mm

7709-7550 7.5mm 50mm

7709-7555 7.5mm 55mm

7709-7560 7.5mm 60mm

7709-7565 7.5mm 65mm

7709-7570 7.5mm 70mm

7709-7575 7.5mm 75mm

7709-7580 7.5mm 80mm

7709-7585 7.5mm 85mm

7709-7590 7.5mm 90mm

7709-7595 7.5mm 95mm

7709-7500 7.5mm 100mm

7709-8525 8.5mm 25mm

7709-8530 8.5mm 30mm

7709-8535 8.5mm 35mm

7709-8540 8.5mm 40mm

7709-8545 8.5mm 45mm

7709-8550 8.5mm 50mm

7709-8555 8.5mm 55mm

7709-8560 8.5mm 60mm

7709-8565 8.5mm 65mm

7709-8570 8.5mm 70mm

7709-8580 8.5mm 80mm

7709-8585 8.5mm 85mm

7709-8590 8.5mm 90mm

7709-8595 8.5mm 95mm

7709-8500 8.5mm 100mm

Set Screws

Part # Description

7703-1600 Set Screw

7902-1000 Set Screw, Small


Rods

Part # Description Size

7701-0500 Rod, Rigid w/ Hex Tips 500mm

7701-2500 Rod, Malleable 500mm w/ Hex Tips

7701-3050 Rod, Template, 500mm Malleable (Disposable)

7701-6500 Rod, Straight 500mm w/ Hex Tips, CoCr

Offset Connectors

Part # Description Size

7702-3015 Offset Connector, Open 15mm



7702-3140 Offset Connector, Closed 40mm

Rod-To-Rod Connectors

Part # Length

7702-4101 Connector, Parallel, 1x2 7702-4102 Connector, Parallel, Extended Body, 1x2 7702-4201 Connector, Parallel, 2x2

7702-4202 Connector, Parallel, Extended Body, 2x2

7702-4400 Connector, Axial

26 BIOMET SPINE

DEVICE DESCRIPTIONTheSilverton®andSilverton-D®systemsareposteriorattachmentspinalfixationsystemscomposedofananatomicallyscaledseriesofpediclescrews,hooks,longitudinalrods,setscrews,nuts,variousconnectors,dedicatedsurgicalinstrumentsandsterilizationcases.Thecomponentsareusedtobuildaconstructtoprovidestabilizationofspinalsegmentsinthethoracic,lumbarandsacralspinetosupportfusion.TheSilvertonandSilverton-DdevicesarepartoftheBIOMETSpinalFixationSystem,whichoffersthesurgeonavarietyofimplantcomponentsfromwhichtoassembleasuitableconstructaccordingtoeachindividualpatient’sneedsandrequirements.Afterasolidfusionoccurs,thesystemservesnofunctionalpurposeandshouldberemoved.Removalisindicatedbecausetheimplantsarenotintendedtotransferorsupportforcesdevelopedduringnormalactivities.However,anydecisiontoremovethedevicemustbemadebythephysicianandthepatient,takingintoconsiderationthepatient’sgeneralmedicalconditionandthepotentialrisktothepatientofasecondsurgicalprocedure.

INDICATIONS FOR USETheSilvertonandSilverton-Dsystemsareintendedtobeusedtohelpprovideimmobilizationandstabilizationofspinalsegmentsinskeletallymaturepatientsasanadjuncttofusionofthethoracic,lumbar,and/orsacralspine.Thesystemisintendedforusewithautograftorallograft.

TheSilvertonandSilverton-Dsystemsareintendedforposterior,non-cervical(T1–S2/Ilium)pedicleandnon-pediclespinalfixation,toprovideimmobilizationandstabilizationofspinalsegmentsinskeletallymaturepatientsasanadjuncttofusioninthetreatmentofthefollowinginstabilitiesordeformities:degenerativediscdisease(asdefinedbybackpainofdiscogenicoriginwithdegenerationofthediscconfirmedbyhistoryandradiographicstudies);spondylolisthesis;trauma(i.e.,fractureordislocation);spinalstenosis;deformitiesorcurvatures(i.e.,scoliosis,kyphosisand/orlordosis);tumor;pseudarthrosis;andfailedpreviousfusion.

CONTRAINDICATIONSContraindicationsmayberelativeorabsolute.Thechoiceofaparticulardevicemustbecarefullyweighedagainstthepatient’soverallevaluation.Circumstanceslistedbelowmayreducethechanceofasuccessfuloutcome.Contraindicationsinclude,butarenotlimitedto:

•Allergytotitaniumorcobaltchromealloys,orforeignbodysensitivity.Wherematerialsensitivityissuspected,appropriatetestsmustbemadepriortoimplantation.

•Knownorsuspectedinfection/immunesystemincompetence.Acuteorchronicinfectiousdiseasesofanyetiologyorlocalization.

•Anyabnormalitypresentwhichaffectsthenormalprocessofboneremodelingincluding,butnotlimitedto,severeosteoporosis

involvingthespine,boneabsorption,osteopenia,activeinfectionatthesiteorcertainmetabolicdisordersaffectingosteogenesis.

•MorbidObesity.Anoverweightorobesepatientcanproduceloadsonthespinalsystemthatcanleadtofailureofthefixationofthedeviceorfailureofthedeviceitself.

•Anyneuromusculardeficitwhichplacesanunusuallyheavyloadonthedeviceduringthehealingperiod.

•OpenWounds.

•Pregnancy.

•Anyothermedicalorsurgicalconditionwhichwouldprecludethepotentialbenefitofspinalsurgery,suchasthepresenceofcongenitalabnormalities,elevationofsedimentationrateunexplainedbyotherdiseases,elevationofthewhitebloodcell(WBC)count,oramarkedleftshiftintheWBCdifferentialcount.

•Anycaserequiringthemixingofcomponentsfromtwodifferentsystems.

•Anycaserequiringthemixtureofstainlesssteelwithtitanium,orstainlesssteelwithcobaltchromeimplantcomponents.

•Feverorleukocytosis.

•Signsoflocalinfectionorinflammation.

•Previoushistoryofinfection.

•Alcoholismorheavysmoking.

•Senility,mentalillnessorsubstanceabuse,ofaseveritythatthepatientmayignorecertainnecessarylimitationsandprecautionsintheuseoftheimplant,leadingtofailureorothercomplications.

•Anypatientunwillingtofollowpostoperativeinstructions.

•Inadequatetissuecoverageovertheoperativesite.

POSSIBLE COMPLICATIONSPossiblecomplicationsspecifictothedevicemayinclude:

•Earlyorlateimplantbending,breakage,failure,looseningormovement/migration

•Bonefracture

•Allergicreactiontoimplantmaterial

Othergeneralcomplicationsassociatedwithanyspinalsurgicalproceduremayinclude:Non-unionordelayedunion,pseudarthrosis;pain;secondsurgery;bleeding;infection,earlyandlate;tissueornervedamage,includingduraltearsorotherneurologicalproblems;incisionalcomplications;scarformation;damagetobloodvesselsandcardiovascularsystemcompromise;changesinmentalstatus;damagetointernalorgansandconnectivetissue;complicationsduetotheuseofbonegrafting,includinggraftdonorsitecomplications;respiratoryproblems;reactionstoanaesthesiaand/ordeath.

IMPORTANT INFORMATION ON THE SILVERTON® SPINAL FIXATION AND SILVERTON-D® DEFORMITY SYSTEMS


WARNINGSThesafetyandeffectivenessofpediclescrewspinalsystemshavebeenestablishedonlyforspinalconditionswithsignificantmechanicalinstabilityordeformityrequiringfusionwithinstrumentation.Theseconditionsaresignificantmechanicalinstabilityordeformityofthethoracic,lumbarandsacralspinesecondarytoseverespondylolisthesis(grades3and4)oftheL5–S1vertebra,degenerativespondylolisthesiswithobjectiveevidenceofneurologicalimpairment,fracture,dislocation,scoliosis,kyphosis,spinaltumorandfailedpreviousfusion(pseudarthrosis).Thesafetyandeffectivenessofthesedevicesforanyotherconditionsareunknown.

Patientswithpreviousspinalsurgeryatthelevelstobetreatedmayhavedifferentclinicaloutcomesthanprevioussurgicaloutcomes.

PRECAUTIONS•TheSilvertonandSilverton-Dimplantsareforsingleuse

only.Neverreuseanyimplantevenifitappearsunmarkedorundamaged.Reuseoftheimplantcomponentsmayresultinreducedmechanicalperformance,malfunctionorfailureofthedevice.Anyimplantimplantedandthenremovedmustbediscarded.Useonlynewimplantsforeachcase.

•Theimplantationofpediclescrewspinalsystemsmustonlybeperformedbyexperiencedspinalsurgeonswithspecifictrainingintheuseofthispediclescrewspinalsystemduetothetechnicallydemandingprocedurepresentingariskofseriousinjurytothepatient.

•Basedonthefatiguetestingresults,thephysician/surgeonmustconsiderthelevelsofimplantation,patientweight,patientactivitylevel,otherpatientconditions,etc.whichmayimpactontheperformanceofthesystem.

•Preoperatively:Thesurgeonmustbefullyconversantwithallaspectsofthesurgicaltechniqueandknowtheindicationsandcontraindicationsofthistypeofimplant.Thesurgeonmusthaveacquaintedhimselfbeforetheoperationwiththespecifictechniqueforinsertionoftheproduct,whichisavailablefromthemanufacturer.Aspartofthepreoperativeexamination,thesurgeonmustcheckthatnobiological,biomechanicalorotherfactorswillaffectthecorrectconductoftheoperationandthepostoperativeperiod.Anappropriaterangeofimplantsizesmustbeavailableatthetimeoftheoperation.

•Intraoperatively:Thecorrectselectionofthetypeandsizeofimplantappropriatetothepatientandthepositioningoftheimplantareextremelyimportant.

•TappingtosizeisrequiredforBIOMETTurretScrewsdiameter8.5mmandlarger.FailuretodosocouldresultindamagetotheBoneScrewDriver.Thismayresultinpatientinjury.

•Failuretoplacethesetscrewasinstructed(goldtopsurfaceisvisiblepriortoinsertion)couldresultinafailureoftheinstrumentationtoproperlylockinplaceasintended.Thismayresultinpatientinjury.

•Postoperatively:Patientsmustbeinformedoftheprecautionstobetakenintheireverydaylifetoguaranteeamaximumimplantservicelife.Itisrecommendedthatregularpostoperativefollow-upisundertakentodetectearlysignsoffailureoftheimplantsandtoconsidertheactiontobetaken.Deteriorationofthedeviceafterboneconsolidationcannotbeconsideredtoconstituteadysfunctionordeteriorationinthecharacteristicsoftheimplants.Theimplantcanberemovedafterbonyhealing.

•TheSilvertonandSilverton-Ddeviceshavenotbeentestedforsafetyandcompatibilityinthemagneticresonance(MR)environment.TheSilvertonandSilverton-DsystemshavenotbeentestedforheatingormigrationintheMRenvironment.

•Mixingofdissimilarmetalscanaccelerateorinitiatethecorrosionprocess.TitaniumcomponentsmustNOTbeusedtogetherinbuildingaconstructthatinvolvesotherimplantmaterials.Titaniumandcobaltchromemaybeusedtogetherwithinthesameconstruct.

IMPORTANT INFORMATION ON THE SILVERTON® SPINAL FIXATION AND SILVERTON-D® DEFORMITY SYSTEMS

PRODUCT COMPLAINTS — Communicate suspected deficiencies in product quality, identity, durability, reliability, safety, effectiveness and/or performance directly to BIOMET SPINE by email: [email protected] or phone: 866.956.7579. When filing a complaint, please provide the component name(s), part number(s), lot number(s), your name and address, the nature of the complaint, surgeon name and the date you became aware of the complaint. Sterilize and return all component(s) to your local BIOMET SPINE representative. Notify BIOMET SPINE immediately of an incident resulting in patient death or serious injury.

If further directions for use of this system are needed, contact BIOMET SPINE Customer Service by email: [email protected], phone: 866.378.4195 or fax: 303.443.7501.

All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to BIOMET Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of BIOMET.

This material is intended for health care professionals and the BIOMET sales force. Distribution to any other recipient is prohibited.

For complete product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert.

This technique was prepared in conjunction with a licensed health care professional. BIOMET does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and product(s) for each individual patient.

Broomfield, CO • 800.447.3625www.biomet.com • LIT7710-0410.02

©2014 BIOMET SPINE, LLC. All rights reserved. All trademarks are the property of BIOMET, Inc. or one of its subsidiaries, unless otherwise indicated. Rx Only.

At BIOMET, engineering excellence is our heritage and our passion. For over 25 years, through various divisions worldwide, we have applied the most advanced engineering and manufacturing technology to the development of highly durable systems for a wide variety of surgical applications.

To learn more about this product, contact your local BIOMET Sales Representative today.

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Surgical Technique Guide - Zimmer Biomet€¦ · spinal stenosis and trauma. 2 ... instrumentation techniques. SURGICAL EXPOSURE AND SITE PREPARATION • Patient positioning is critical