trinnect™ hydrated anterior cervical spacer system - · pdf filethe trinnect™...

Surgical Technique

Trinnect™ Hydrated Anterior Cervical Spacer System

• Preservon†retainsmechanicalstrengthbyeliminatingthepotentialbrittlenessassociatedwithfreezedrying

• Load-bearingcorticaledgesprovidestructuralintegritywhilethelargecancellouscenterallowsforosteointegration

• Readyforuseinunder30secondswithouttheneedforrehydration

B

Contents

Introduction................................................ Page1

ProductOverview(DesignFeatures).......... Page1

FeaturesandBenefits.................................. Page2

Instruments................................................ Page3

SurgicalTechnique..................................... Page4

IndicationsforUse...................................... Page7

OrderingInformation.................................. Page8

FurtherInformation..................................... Page9

1

Trinnect™AllograftSpacersarecomposedofcorticalbonefor

structuralintegrityanddensecancellousboneforintegration.

Thegraftfeaturestwopiecesofcorticalbonetoformthe

lateralaspectsofthegraftwithcancellousboneinthecenter.

ThefootprintoftheTrinnect™Spacermeasures14.5mm

widewithadepthof11.5mm.Availableheightsrangefrom

5mmto12mmin1mmincrements.Thespacerfeatures7°of

lordosistocloselyapproximatethecurvatureofthecervical

spine.Inaddition,eachgraftismachinedwithhorizontal

ridgestoprovideexpulsionresistance.

Cancellous

Cortical Cortical

Introduction Product Overview (Design Features)

TheTrinnect™HydratedAnteriorCervicalSpacerSystemisa

lineofprecision-machinedcervicalallograftspacers.

Trinnect™AllograftSpacersareprocessedbyLifeNetHealth†,

whichisaccreditedbytheAmericanAssociationofTissue

Banks(AATB).Trinnect™AllograftSpacersarepackaged

usingPreservon†,aglycerol-basedpreservationtechnology,

allowingthespacertobestoredinafullyhydratedstateat

ambienttemperature,eliminatingtheneedtofreezeor

freeze-drythespacers.

2

Features and Benefits

• Preservon†retainsmechanicalstrengthbyeliminatingthepotentialbrittlenessassociatedwithfreezedrying

• Load-bearingcorticaledgesprovidestructuralintegritywhilethelargecancellouscenterallowsforintegration

• Readyforuseinunder30secondswithouttheneedforrehydration

3

Instruments

TheTrinnect™HydratedAllograftimplantsetoffersaunique

setofinstrumentationthatissimpletouseanddesigned

withtheintentofmakingadirectcontributiontosuccessful

clinicalresults.

Slotted Mallet Head

Trial with Stops

Trial without Stops

Rasp with Stops

Rasp without Stops

Cervical Spacer Inserter

5mm Tamp

4

Surgical Technique

Usingastandardsurgicalapproach,exposethevertebral

bodiestobefused.Traditionalcervicalretractorsmaybe

used.Preparethefusionsitefollowingtheappropriate

techniqueforthespecificindication.

Step 1: Vertebral Body Distraction

Ifusingdistractionpins,placeonedistractionpininthe

vertebralbodysuperiortotheaffectedlevelandtheother

distractionpininthevertebralbodyinferiortotheaffected

level.Thepindistractorisplacedoverthepinsandopenedas

neededtodistractthevertebralbodies.

Step 2: Discectomy and End-Plate Preparation

Usingrongeurs,pituitariesandcurettes,removethe

intervertebraldiscandosteophytesasneeded.Rasps

canalsobeusedtopreparetheendplatesandexpose

bleedingbone.

Thetrialsandraspsaredouble-sidedforefficiency.These

instrumentscorrespondtotheimplantfootprintsandare

availablein5mm–12mmheightsin1mmincrementssimilar

totheimplants.Theraspsaredesignedsothattheteethcut

onthebackstrokeastheinstrumentisbeingpulledaway

fromthespinalcord.

CAUTION:Aggressivepreparationoftheendplatemay

removeexcessiveboneandweakentheendplate.

5

Step 3: Implant Sizing

Usingthedouble-sidedraspsortrials,determinethe

appropriateimplantsizebysizingthediscspace.When

sizing,useincrementallylargersizesuntilatightfitis

achieved.Asecurefitisdesirabletomaintaindischeightand

stabilizethesegment.Thereshouldbenogapsbetweenthe

preparedsizeandtrialorrasp.

Thetrialsandraspsarebothavailablewithorwithoutstops.

Thestopsallowforamaximumof2mmofcountersinkinto

thediscspace.

Oncethedesireddischeightisdetermined,selectthe

appropriateTrinnect™implant.

Step 4: Implant Insertion

Loadthegraftontotheinserterbyplacingitbetweenthe

tinesandturntheknobattheproximalendoftheinserter

clockwisetofullyengagetheimplant.

Introducetheimplantintothevertebraldiscspaceusingthe

inserter.Theimplantshouldbethesameheightasthesize

determinedbythetrialandshouldbeseatedsecurelywithin

thediscspace.Taptheproximalstrikeplateoftheinserter

withamallettogentlyseattheimplant.Theimplantmaybe

insertedflushwiththeanteriorrimoftheadjacentvertebral

bodiesormaybecountersunkpasttheanteriorrimatthe

physician’sdiscretion.

6

Disengagetheimplantfromtheinserterandremove

theinstrument.Thetampmaybeutilizedtofurther

advancetheimplantintothediscspaceifdesired.

RepeatstepstoinsertadditionalTrinnect™Spacer

Systemimplantsatadditionalintervertebrallevels.

Proceedwiththeapplicationofanteriorcervical

instrumentationandclosure.

Surgical Technique (Continued)

7

Description

Thisallograftspacerwasprocessedfromdonatedhuman

tissue,resultingfromthegenerousgiftofanindividualor

his/herfamily.Thespacerwascleanedanddisinfected

throughaproprietaryprocessandterminallysterilizedvia

gammairradiation.

Therearetwopreservationmethodsincludedinthese

instructions:Freeze-Dried,andpackagedwithPreservon†.

Pleaserefertothelabeltoidentifywhichpreservationmethod

wasutilizedforthisspacer.

Indications for Use

Thisallograftspacerisintendedforimplantation.

Contraindications

Thecontraindicationsinclude,butarenotlimitedto:

• Useinanypatientwhohasaknownorsuspectedallergy toanyoftheantibioticsand/orprocessingreagentslisted

inthispackageinsert

Warnings and Precautions

Thesamemedical/surgicalconditionsorcomplications

thatapplytoanysurgicalproceduremayoccurduring

orfollowingimplantation.Thesurgeonisresponsiblefor

informingthepatientoftherisksassociatedwiththeir

treatmentandthepossibilityofcomplicationsoradverse

reactions.Aswithanyallograftspacer,thetransmissionof

infectiousagentsexists.

Thisspacermaycontainresidualsofantibiotics(Bacitracin,

Gentamicin,and/orPolymyxinBSulfate),alcohol,

surfactants,and/orglycerol.Cautionshouldbeexercisedif

thepatienthasaknownsensitivitytoanyoftheseantibiotics

and/orreagents.

Potential Adverse Events

Potentialadverseeventsoroutcomesinclude,butarenot

limitedto,diseasetransmission,infection,allografttissue

rejection,allergicreactiontoresidualprocessingreagents,

reoperationand/ordeath.

Promptlyreportanyadverseevent(s)oroutcome(s)

potentiallyattributabletotheallograftspacer.

Safety

Alldonorshavebeenscreenedandtissuesrecovered,

processed,stored,testedanddistributedinaccordancewith

currentU.S.federalregulationsaspromulgatedin21CFR

1270and1271,currentStandardsforTissueBankingset

forthbytheAATBandinternationallawsandregulations

asrequired.Moreinformationcanbefoundinthedonor

screeningandtestingsectionofthepackageinsert.

Indications for Use

8

Ordering Information

Trinnect™ Hydrated Anterior Cervical Allograft Implant Kit

(Catalog No. 14-531209)

Catalog # Description Qty/Set

LNHC05 Hydrated5mmLordoticCervicalGraft

2


3


4


4


4


3


2


2

Trinnect™ Hydrated Anterior Cervical Allograft Instrument

Kit (Catalog No. 14-531208)

Catalog # Description Qty/Set

14-531640 Trial5/6Hx14Wx12DwithStops

1


1


1


1

14-531750 Trial5/6Hx14Wx12DwithoutStops

1


1


1


1

14-531830 Rasp5/6Hx14Wx12DwithStops

1


1


1


1

14-531890 Rasp5/6Hx14Wx12DwithoutStops

1


1


1


1

14-531141 CervicalSpacerInserter 2

14-531142 5mmTamp 1

14-531563 SlottedMalletHead 1

9

Further Information

Allcontenthereinisprotectedbycopyright,trademarksand

otherintellectualpropertyrightsownedbyorlicensedto

BiometInc.oritsaffiliatesunlessotherwiseindicated,and

mustnotberedistributed,duplicatedordisclosed,inwhole

orinpart,withouttheexpresswrittenconsentofBiomet.

Thismaterialisintendedforhealthcareprofessionalsand

theBiometsalesforce.Distributiontoanyotherrecipient

isprohibited.

Forcompleteproductinformation,includingindications,

contraindications,warnings,precautions,andpotential

adverseeffects,seethepackageinsert.

Thistechniquewaspreparedinconjunctionwithalicensed

healthcareprofessional.Biometdoesnotpracticemedicine.

Thetreatingsurgeonisresponsiblefordeterminingthe

appropriatetreatment,technique(s),andproduct(s)foreach

individualpatient.

Forfurtherinformation,pleasecontacttheCustomerService

Departmentat:

BiometSpine

310InterlockenParkway,Suite120

Broomfield,CO80021

303.443.7500or800.447.3625

biometspine.com

Broomfield,CO•800.447.3625biometspine.com•LIT0010-0114.0106/14

©2014BiometSpine,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.,oroneofitssubsidiaries,unlessotherwiseindicated.†Denotesathirdpartytrademark.RxOnly.

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

Trinnect™ Hydrated Anterior Cervical Spacer System

trinnect™ hydrated anterior cervical spacer system - · pdf filethe trinnect™...

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