MSD 1 123
`|PR2013—00506
`
`|PR2013—00508
`
`
`|PR2013—00506
`
`|PR2013—00508
`
`
`
`BUTTERFLY
`
`Al\"l'l:'.RI(_)R L-\'l'l:IR.*'tL I‘-IX*\'l1()N SY.‘-i’ l'l'lM
`
`Standard Plates
`Length: 48mm and 495mm
`
`Standard Cages
`Diameter: 14mm or 16mm
`Length: 30mm, 35mm, or 40mm
`
`The BUTTERFLY system has been
`
`designed to answer the growing need for
`an anterior lateral plate and offers
`
`advanced product features:
`
`-
`
`-
`
`Provides significant supplementary fixation to
`an interbody construct
`
`Low profile lumbar anterior lateral plate for
`L4-5 and higher levels
`
`- Anatomical fit between the concavity of the
`vertebral wall and the BUTTERFLY plate
`_
`_
`_
`- Mini-open of endoscopic approach
`
`- Option of using a threaded cage which can be
`attached to the BUTTERFLY plate
`
`— Option of using the BUTTERFLY plate in
`conjunction with a anterior lateral impacted
`
`cage.
`
`" __ _
`
`_
`
`.
`
`_ _
`
`-
`
`
`
`4." — ._
`
`Used in conjunction
`with a Union-L
`
`Cage
`
`Pre-op
`51 year old female,
`painful discopathy
`with intermittent
`
`radicular pain, bulging
`disc on MRI.
`
`Post-op
`Post-op L4-5 anterior lateral
`arthrodesis with UNlON interbody
`cage and BUTTERFLY plate Complete
`
`restoration of the foramen height.
`
`
`
`
`
`
`
`
`600
`
`500
`5 400
`3; 300
`3 200
`100
`
`
`
`MaximumCompressive
`
`
`
`Mechanical Test
`
`The Butterfly Plate went under the static
`fatigue compression tests under ASTM
`F1717 corpectomy model. it showed that
`the Butterfly Plate presents a high level of
`mechanical strength.
`
`Biomechanical Test
`
`The Butterfly Plate went through
`biomechanical tests on human cadaver
`
`models. It showed that the Butterfly Plate
`provided significant supplementary
`stabilization to the spine.
`
`
`
`.96:-A-id
`
`
`
`Range of Motion
`
`2.2
`2
`1 .8
`1 .6
`1 .4
`1 .2
`1
`.8
`.6
`.4
`.2
`0
`
`_
`
`Intact
`Spine
`
`+ Cage
`
`+ Cage
`+ Plate
`
`4- Cage
`+ Plate
`+ Nut
`
`Pre-op
`Male, L4-5 foraminal
`
`stenosis with painful
`discopathy and loss of
`disc height.
`
`Post-op
`L4-5 anterior lateral approach for
`interbody arthrodesis using BUTTERFLY
`cage and plate.
`
`Attached with a Butterfly Cage
`
`.;
`
`Maximum Compression Load
`
`V
`
`-culur
`
`-
`
`
`7lIIIIII|| EIIIIIIIII ill:
`
`
`
`
`
`
`
`
`
`
`fl-IIIIIIII EIIII
`?lK‘I!IIl|I
`.1‘;-II:!!lI_ T ii-IIIIIIII
`lillll
`TIIIIIIIII
`;$=El!!!!!! EEIIIIIIII
`Tifllllllll Zilllllllll
`IEIIIIIIII
`ilIIII||l
`ill-Illlllll
`ilillllllll
`
`
`
`100000
`100000
`10000000
`1000
`
`Number of Cycles
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`Page 5
`
`Page 5
`
`Page 6
`
`Page 6
`
`Page 7
`
`Page 8
`
`Page 9
`
`Page 10
`
`Page 11
`
`Page 12
`
`Page 13
`
`Page 14
`
`Page 15
`
`Page 16
`
`Page 17
`
`Page 18
`
`Page 19
`
`Table of Contents
`
`Indications
`
`Contraindications
`
`Butterfly"“ Plate & Cage
`
`Patient Positioning and Surgical Exposure
`
`Discectomy
`
`Partial Discectomy
`
`Guide Sleeve Distractor assembly
`
`Disc Distraction and Guide Sleeve Seating
`
`Endplate Reaming
`
`Cage packing and implantation
`
`Plate installation
`
`Insertion of screws
`
`Butterfly Plate & Union-L"“
`
`Bolt insertion
`
`Plate insertion with Union” Cage
`
`Postoperative care
`
`Set composition Union-L”
`
`Set composition lnterfix—lateral
`
`Set composition Butterfly
`
`
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`
`
`ButterflyPlate&Cage
`
`INDICATIONS
`
`Generally indicated for lumbar and Iumbosacral
`pathologies indicated for segmental arthrodesis including:
`
`- Degenerative discopathy:
`
`- Primary surgery for advanced discopathies or
`extensive destabilizing decompressions
`
`— Revision surgery for failed disc surgery,
`(recurrent disc herniation, post-operative instability)
`
`- Lumbar pseudarthrosis
`- Certain lumbar stenosis
`
`CONTRAINDICATIONS
`
`This device is not intended for cervical spine use.
`Contraindications include, but are not limited to:
`
`Infection, local to the operative site
`
`Signs of local inflammation
`
`Fever or leukocytosis
`
`Morbid obesity
`
`Pregnancy
`Mental illness
`
`Rapidjoint disease, bone absorption, osteopenia,
`osteoporosis
`
`Suspected or documented allergy or intolerance to
`composite materials
`
`Patients with a known hereditary or acquired bone
`friability or calcification problem should not be considered
`for this type of surgery
`
`These devices should not be used for pediatric cases, nor
`where the patient still has skeletal growth
`
`Spondylolisthesis unable to be reduced to Grade 1
`
`Any cases where the implant components selected for use
`would be too large or too small to achieve a successful
`result
`
`Any case that requires the mixing of metals from two
`different components or systems
`
`Any patient having inadequate tissue coverage over the
`operative site or inadequate bone stock or quality
`
`Any patient in which implant utilization would interfere
`with anatomical structures or expected physiological
`performance
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`PATIENT POSITIONING AND SURGICAL EXPOSURE
`
`The following selection describes the procedure using the
`Lateral Approach.
`
`The patient is placed in a right decubitus lateral position
`on the operating table. An oblique skin incision is made
`above the center of the targeted disc space. Exposure to
`the lateral aspect of the spine is obtained by a
`retroperitoneal approach. Psoas muscle is retracted
`posteriorly and held in place with the help of a retractor.
`Confirm the fusion level by means of lateral fluoroscopic
`control.
`
`A mini—ALlF approach can be made with the help of the
`Medtronic Sofamor Danek ENDORING retractor system.
`
`DISCECTOMY
`
`Perform about a 2.5mm wide lateral block discectomy.
`Using a Disc Rongeur to remove the disc material.
`
`Endplate preparation is carried out using surgical chisels
`and curettes. Remove the cartilage from the endplates to
`obtain a large flat surface on subchondral bone and a
`bleeding area in the center of the endplate.
`
`
`
`
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`PARTIAL DISCECTOMY
`
`The Guide Wire is placed into the Trephine and then
`approached to the entrance point on the disc. Before
`trephining, slightly impact the Guide Wire into the disc in
`order to avoid any slippage. A pre—perforation of the disc is
`performed with the Trephine until the stop level is
`reached.
`
`A—P and lateral fluoroscopic checks are recommended to
`confirm the targeted lumbar level and to ensure the safe
`trajectory of the trephine.
`
`The opening on the disc is enlarged with the help of the
`Cobb and the Kerrison in the set.
`
`Discectomy is performed, but the annulus is preserved to
`increased mechanical stability by tensioning the remaining
`annular and ligamental structures of the disc. The
`instrumentation will simultaneously remove the required
`volume of the disc and prepare the adjacent vertebral
`endplates for the fusion implant.
`
`
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`GUIDE SLEEVE DISTRACTOR ASSEMBLY
`
`Attach the Distractor head to the Implant lnserter. The
`number marked on the Distractor head indicates the
`
`distraction height in mm.
`
`Choose the corresponding Guide Sleeve, the first number
`marked on the sleeve should match that of the Distractor
`
`Head. Assemble the Guide Sleeve with the Implant
`lnserter and the Switching Sleeve in the following manner:
`
`. Hold the Implant lnserter and keep pushing the sliding
`bloc,
`
`. Slide the Switching Sleeve on the implant lnserter and
`turn it to find the indexed position,
`
`. Slide the Guide Sleeve onto the Switching Sleeve and
`find the indexed position,
`. Turn the slack collar on the Protection Sleeve for
`
`connecting.
`
`‘
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`DISC DISTRACTION AND GUIDE SLEEVE SEATING
`
`Introduce the assembly (long blade anterior) into the disc
`space through the prepared opening and impact it slightly
`with a mallet until it is firmly seated into the disc space. A
`lateral fluoroscopic control is recommended at this stage.
`
`Loosen completely the slack collar to disconnect the
`assembly. Turn the T—Handle 90° to open the disc space.
`The Distractor Head should be firmly held into the disc
`space, othenNise choose a larger Distractor Head and the
`corresponding Guide Sleeve, (go back to Step 2).
`
`Re-orientate the extension blades on the Guide Sleeve to
`
`the disc space. Be sure that the longer extension blade is
`placed to the anterior side of the spine and the curved end
`of the Guide Sleeve matched the border of the vertebral
`
`endplates. Place the lmpactor on the Guide Sleeve. Impact
`it with a mallet until both extension blades are completely
`inserted into the disc space and the Guide Sleeve firmly
`seated against the vertebral bodies.
`
`NOTE: Prior to impacting, make sure that all surrounding
`delicate soft tissues are clearly identified and adequately
`retracted.
`
`
`
`Illlilllll
`
`
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`F lllllllllllllll
`
`ENDPLATE REAMING
`
`Remove the Distractor and the Switching Sleeve from the
`Guide Sleeve. At this stage of the surgery, A—P and lateral
`fluoroscopic controls are recommended to confirm the
`proper disc distraction and the correct placement of the
`Guide Sleeve.
`
`The implant can be precisely determined in the following
`way.
`
`Distractor Size
`
`8mm
`
`Implant Diameter
`
`14 or 16mm
`
`10mmm
`16mm
`
`12mm
`|
`| 18 or 20mm
`
`14mm
`20mm
`
`As the anterior extension blade is measured 30mm in
`
`length, the A—P fluoroscopic image can help to determine
`the implant length.
`
`The Reamer is used to complete the discectomy and
`endplate preparation. The number marked on the Reamer
`corresponds to the diameter of the cage to be used. Set the
`adjustable stop to the first line which corresponds to a
`35mm reaming depth. Place the Reamer into the Guide
`Sleeve and turn it clockwise until the stop level is reached.
`Several passes of reaming process need to be performed
`while cleaning the disc debris attached to the reamer after
`each pass.
`
`A deeper reaming depth can be adjusted every 3mm,
`based on fluoroscopic check, by loosening the collet and
`resetting.
`
`After each reaming process, any remaining loose disc
`material should be removed by using the IVD Rongeur
`through the protection Sleeve.
`
`
`
`
`
`
`
`
`
`The implant is placed on the Implant Support in an upright
`position and the cap is removed. The Graft Impactor is
`used to gently compact the morsalized fragments into the
`Implant to ensure the Implant is completely filled. The cap
`is place on the implant.
`Attach the Butterfly Implant to the implant lnserter. Place
`the Implant lnserter into the Guide Sleeve and begin
`screwing the Implant into the prepared disc space until the
`predetermined depth indication reaches the border of the
`Guide Sleeve. The cage should be positioned about
`2-3mm countersink to the lateral wall.
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`CAGE PACKING AND IMPLANTATION
`
`Detach the Implant lnserter after the cage position is
`confirmed by A—P and lateral fluoroscopic check. Connect
`the Wrench to the Guide Sleeve. Remove the Protection
`
`Sleeve with the help of the Fork Hammer.
`
`NOTE: We recommend to use a cage of 5mm shorter than
`the measured depth in order to place cancellous bone in
`the disc space before cage insertion.
`
`
`
`PLATE INSTALLATION
`
`Slide the Cage Adjuster into the Nut Driver. Attach the Nut
`to the Cage Adjuster. Take the Butterfly Plate with the Plate
`Holder, turning the outer sleeve down in order to firmly
`attach the Plate. Slide both the Cage Adjusters and the Nut
`Driver into the Plate Holder.
`
`Introduce the assembly into the operation field through the
`skin opening. Attach the cage Adjuster to the Cage. Slide
`down the Plate Holder and push the Plate firmly against
`the vertebral bodies. Adjust the cage position by screwing
`or unscrewing in order for the cage to be in contact with
`the Plate.
`
`Turn the Nut Driver to release the Nut and bring it to the
`threaded end of the cage. Tighten the Nut to fix the Plate
`onto the cage.
`
`Insert the Z—Plate screws in to the vertebral bodies through
`the holes of the Plate.
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`l
`
`I.u.-n
`;t'~_*-_'~.m'-.‘«.itr
`0uIp
`
`
`
`BUTTEQFLY
`
`FUSION SY TENI
`
`INSERTION OF SCREWS
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`
`
`UNION-
`DEVICE
`LATERAL IMPACTED
`F” 5 ' ‘3 N
`
`
`Option with the Union-L"" cage
`
`Insertion of the cage - refer to Union-L“ Surgical Technique
`
`BOLT INSERTION
`
`
`
`BEIIMLY
`
`PLATE INSERTION WITH UNION CAGE
`
`<lI!|!'4Mll?Ill|D
`
`
`
`ammo._-:o_::wbtmzzm
`
`1:
`
`
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`POST-OPERATI VE CARE
`
`Wound closure is carried out in a routine manner.
`
`Ambulation begins when tolerated, usually the following day.
`Keep patient calm for first 3 days.
`
`16
`
`
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`SET COMPOSTION UNION-L“
`
`UNION” & UNION-L” INSTRUMENTS
`
`GENERAL INSTRUMENTS UNION
`175106
`175108
`
`Guide Tip 6
`Guide Tip 8
`Trial 10/26
`
`175110
`175112
`
`1750114
`1750116
`
`175210
`175212
`
`1750214
`1750216
`
`175120
`175122
`
`1750124
`1750126
`
`175220
`
`175222
`1750224
`
`1750226
`
`175126
`
`175128
`
`175136
`175138
`
`175426
`
`175431
`
`175502
`175503
`
`175506
`
`8954DR00
`
`175109
`
`1750310
`
`1750312
`1750314
`
`1750316
`
`1750130
`
`1750132
`1750134
`
`1750136
`
`1750230
`1750232
`
`1750234
`
`1750236
`
`Trial 12/26
`
`Trial 14/26
`Trial 16/26
`
`Trial 10/31
`Trial 12/31
`
`Trial 14/31
`
`Trail 16/31
`
`Rail Cutter 10/26
`Rail Cutter 12/26
`
`Rail Cutter 14/26
`
`Rail Cutter 16/26
`
`Rail Cutter 10/31
`Rail Cutter 12/31
`
`Rail Cutter 14/31
`
`Rail Cutter 16/31
`Protection Tube 6/26
`
`Protection Tube 8/26
`
`Protection Tube 6/31
`
`Protection Tube 8/31
`Handle 26
`Handle 31
`
`lmpactor Cap
`Fork Hammer
`
`Graft lmpactor
`Disc Rongeur
`Connection Pin
`
`Lateral Distractor Tip
`Lateral Trial M10
`Lateral Trial M12
`Lateral Trial M14
`
`Lateral Trial M16
`
`Lateral Rail Cutter M10
`
`Lateral Rail Cutter M12
`
`Lateral Rail Cutter M14
`
`Lateral Rail Cutter M16
`Lateral Guide 10
`
`Lateral Guide 12
`Lateral Guide 14
`
`Lateral Guide 16
`
`GENERAL INSTRUMENTS UNION-L
`1750300
`
`
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`SET COMPOSTION IN TERFIX-LATERAL
`
`INTERFIX-LATERAL INSTRUMENTS
`
`GENERAL INSTRUMENTS
`
`894.093
`
`Guide Wire
`
`896.103
`
`Wrench
`
`896.104
`
`Fork Hammer
`
`896.105
`
`Trephine 8
`
`896.106
`
`Trephine 10
`
`950.940
`
`IVD Rongeur
`
`950.931
`
`Kerrinson 5mm
`
`896.101
`
`Bone Graft lmpactor
`
`950.902
`
`Cobb
`
`896.102
`
`lmpactor
`
`14/16mm Instruments
`
`896.508
`
`Distractor Head 8
`
`896.510
`
`Distractor Head 10
`
`896.346
`
`Implant Inserter 14/16
`
`896.414
`
`Protection Sleeve 8/14,16
`
`896.416
`
`Protection Sleeve 10/16
`
`896.646
`
`896.746
`
`Switching Sleeve 14/16
`
`Adapter Sleeve 14/16
`
`895-IBFOO Adjustable Reamer Stop
`
`896.214
`
`Reamer 14
`
`896.216
`
`Reamer 16
`
`
`
`SET COMPOSTION BUTTERFLY
`
`BUTTERFLY IMPLANTS & INSTRUMENTS
`
`IA4PLAfUT$
`8965001
`8966430
`8966435
`8966440
`8966630
`8966635
`8966640
`
`Plates
`8968848
`8968849
`
`Bolts
`8962630
`8962635
`8962640
`8962645
`843-160
`
`Butterfly Nut
`Butterfly Cage 14/30
`Butterfly Cage 14/35
`Butterfly Cage 14/40
`Butterfly Cage 16/30
`Butterfly Cage 16/35
`Butterfly Cage 16/40
`
`Plate 48mm
`Plate 49.5mm
`
`Butterfly Bolt D6.5 L30
`Butterfly Bolt D6.5 L35
`Butterfly Bolt D6.5 L40
`Butterfly Bolt D6.5 L45
`Nut Bolt
`
`Bone Screw (Z-Plate Screws)
`822-230
`Bone Screw D6.5 L30
`822-235
`Bone Screw D6.5 L35
`822-240
`Bone Screw D6.5 L40
`822-245
`Bone Screw D6.5 L45
`
`INSTRUMENTS
`
`Butterfly Plate Holder
`8961010
`Butterfly Cage Holder
`8961030
`Butterfly Nut Holder
`8961020
`Butterfly Cage Support
`8961040
`Butterfly Gauge
`8961050
`Butterfly Bolt Gauge 48
`8963048
`Butterfly Bolt Gauge 49.5
`8963049
`Butterfly Bolt Holder 1
`8963010
`Butterfly Bolt Holder 2
`8963020
`Butterfly Awl
`8963060
`8963070 Butterfly Bolt Nut Holder
`8963080 Butterfly Screw Holder
`8963090 Butterfly Std Handle
`
`BOX
`
`8969100 Butterfly Container/Base Tray
`8969110 Butterfly Insert Tray
`8969200 Butterfly Lid
`
`BUTTERFLY
`
`FUSION SYSTEM
`
`19
`
`
`
`MEDTRONIC SOFAMOR DANEK EUROPEAN SPINE CENTER
`ZAC PARIS NORD II
`13 RUE DE LA PERDRIX
`BP 50302
`95940 ROISSY CDG CEDEX
`FRANCE
`Tel: +33 1 49 38 80 00 Fax: +33 1 49 38 80 01
`
`SOFAMOR SNC
`RCS Boblgny 3517 320 486- NAF 3313
`
`MEDTRONIC SOFAMOR DANEK FRANCE
`ZAC PARIS NORD II
`22 Avenue des Nations
`Bat le Rousseau
`BP 50406
`95944 ROISSY CDG CEDEX
`FRANCE
`Tel: +331 49 90 84 00 Fax:+331 49 90 84 99
`
`MEDTRONIC SOFAMOR DANEK GMBH
`265 Kiilner Strasse
`51149 KOLN
`GERMANY
`Tel: +49 22 03 91 19 20 Fax: +49 22 O3 91 19 21
`
`MEDTRONIC SOFAMOR DANEK ITALIA SRL
`Via Archimede 31/33
`20041 AGRATE BRIANZA (MI)
`ITALY
`Tel: +39 039 651 643 Fax: +39 039 652 383
`
`MEDTRONIC SOFAMOR DANEK
`Burgemeester Stramanweg 101, 5th Floor
`1101 AAAMSTERDAM Z.O.
`THE NETHERLANDS
`Tel: +31 205 602 950 Fax: +31 206 962 694
`
`MEDTRONIC SOFAMOR DANEK
`SOUTH AFRICA
`1 East Gate Lane, Bedfordview
`JOHANNESBURG 2047
`Rgpuguc OF SOUTH AFR|CA
`Tel: +27 11 616 2334 Fax: +27 11 6221555
`
`MEDTRONIC SOFAMOR DANEK IBERICA, S.A.
`c/Calendula, 93
`Edificio « Medtronlc G »
`El solo de la Moraleja - Alcobendas
`28109 ALCOBENDAS (MADRID)
`SPAIN
`Tel: +34 916 250 500 Fax: +34 916 250 580
`
`MEDTRONIC SOFAMOR DANEK U.K.
`The Bulse Grange
`Wendens Ambo, Saffron Walden
`CB11 4JT
`UNITED KINGDOM
`Tel: +44 17 99 54 25 67
`
`Fax: +44 17 99 54 25 66
`
`|v||=_[)TR()|\||c SOFAMOR DANEK BELGIUM
`Herenthoutseweg 236
`B-2200 HERENTALS
`BELGIUM
`Tel: +3214 3214 70 Fax: +32 14 3214 80
`
`ME[)TRON|c OsTERR|cHE GMBH
`Millenium Tower
`Handelskai 94 » 96
`1200 WIEN
`AUSTRIA
`Tel: +43 124 044 130 Fax: +43 124 044 330
`
`MEDTRONIC AG
`Bahnhofstr. 60
`CH-8600 DUBENDORF
`SWITZERLAND
`Tel: +41 1 802 70 00 Fax: +41 1 802 70 10
`
`MEDTRONIC SOFAMOR DANEK PORTUGAL
`Rua Tomas da Fonseca
`T0rre<E‘8-A/B
`1500309 LISBOA
`PORTUGAL
`Tel: +35 12 17 24 51 00 Fax: +35 1217 24 51 99
`
`
`
`NOT FOR DISTRIBUTION IN THE UNITED STATES
`
`CG 0123
`
`
`
`
`
`REFB0175-01MEDTRONICSOFAMORDANEK06/2001-allrightsreserved
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