TELAMON®
`Posterior Impacted Fusion Devices
`
`MINIMAL ACCESS SPINAL TECHNOLOGIESSM
`
`MSD 1108
`
`1
`
`

`

`Table of Contents
`
`Page 2
`
`Preoperative Planning and Patient Positioning
`
`Page 2
`
`Dilation/Tubular Retraction
`
`Page 3
`
`Tubular Retraction Insertion
`
`Page 3
`
`Discectomy
`
`Page 4
`
`Disc Space Distraction
`
`Page 4
`
`Disc Space Distraction – Rotate Cutter
`
`Page 5
`
`Disc Space Preparation – Round Scraper
`
`Page 5
`
`Endplate Preparation – Cutting Chisel
`
`Page 6
`
`Removal of Cutting Chisels
`
`Page 6
`
`Cage Insertion
`
`Page 7
`
`Cage Insertion
`
`Page 8
`
`Stabilization
`
`Page 9
`
`Notes
`
`1
`
`2
`
`

`

`Preoperative Planning
`
`Spinal needle is placed into
`paraspinous musculature 2-2.5cm
`off of midline at the appropriate level
`confirmed using lateral fluoroscopy.
`• The spinal needle is removed and
`a vertical incision is made at the
`puncture site.
`• The Guidewire is placed through
`the incision and directed toward
`the inferior aspect of superior
`lamina under lateral fluoroscopy.
`
`Dilation/Tubular Retraction
`
`Insert initial cannulated soft tissue
`Dilator over the Guidewire. Once the
`fascia is penetrated, remove the
`Guidewire and advance the Dilator
`down to the inferior edge of superior
`lamina. Confirm the placement of
`initial Dilator using lateral fluoroscopy.
`• Use the initial Dilator to palpate
`the lamina in both the coronal and
`sagittal planes.
`• The tip of the Dilator is used to
`sweep the paraspinal musculature
`off the laminar edge.
`• This maneuver affirms coronal
`placement and expedites soft
`tissue removal.
`• The second, third, fourth and fifth
`Dilators are placed over the initial
`Dilator down to the lamina.
`• Use depth markings on the Dilator
`to determine the correct Tubular
`Retractor length.
`
`2
`
`3
`
`

`

`Tubular Retraction Insertion
`
`• The Flexible Arm is attached to the
`Tubular Retractor.
`• The Tubular Retractor is placed over
`the sequential Dilators, docking on
`the lamina.
`• It is important to always apply
`downward pressure while adjusting
`the Flexible Arm.
`• Repeat muscle dilation and place
`the second Working Channel on the
`opposite side.
`• Fluoroscopy is used to confirm
`appropriate positioning.
`
`Discectomy
`
`• A conventional discectomy is
`performed by incising the annulus
`with a 15-scalpel blade lateral to the
`dural sac.
`• This is done bilaterally and then soft
`fragments from the intradiscal space
`or extruded fragments are removed
`with Disc Rongeurs in a conventional
`fashion.
`The main goal of this step is to remove
`extruded fragments, to decompress
`neural elements, and to provide entry
`to the disc space for distraction with
`minimal or no nerve root retraction.
`If there is significant disc space
`collapse, a complete discectomy may
`not be possible until disc space
`distraction is accomplished.
`
`First Dilator
`Insertion
`
`Sequential Dilation
`and Tubular Retractor Insertion
`
`Soft Tissue Removal
`
`Ligamentum Flavum Removal
`
`Nerve Root Retraction
`
`Discectomy
`
`3
`
`4
`
`

`

`Disc Space Distraction
`
`The disc space is sequentially
`distracted until original disc space
`height is obtained and normal
`foraminal opening is restored.
`• Insert the Distractor with the
`T-handle attached, with the flat
`surface parallel to the endplates.
`• Rotate the Distractor 90 degrees
`to distract the space and remove
`the T-handle.
`• Sequentially insert Distractors from
`side to side until the desired height
`is obtained.
`• The largest Distractor is left in
`the disc space in the distracted
`position while continued disc space
`preparation is performed.
`
`Disc Space Preparation - Rotate Cutter
`
`• The smallest Rotate Cutter is inserted
`into the disc space with the cutting
`blades parallel to the dural sac.
`• The Rotate Cutter is rotated once or
`twice at a depth of 20mm to remove
`osteophytes at the dorsal endplate.
`Removing osteophytes facilitates
`placement of the Cutting Chisel later
`in the procedure.
`• The Rotate Cutter is then inserted up
`to a depth of 30mm and rotated to
`remove residual intradiscal material.
`
`4
`
`5
`
`

`

`Disc Space Preparation - Round Scraper
`
`• Remaining soft tissue or cartilaginous
`endplate covering are removed with
`vigorous scraping or curettage.
`• Scrape medially under the midline
`and gradually work laterally in a
`sweeping motion until both caudal
`and cephalad endplates are cleared of
`soft tissue.
`• The removal of the soft tissue from
`the endplate surface allows optimal
`graft incorporation.
`
`Endplate Preparation - Cutting Chisel
`
`**Keep in mind to chisel to a depth that allows for the
`length of the graft plus 3mm to 4mm of countersink.
`To implant a 20mm graft, the surgeon should chisel
`to 30mm which allows for the length of the graft,
`countersink, and the 5mm lateral extensions.
`To insert a 26mm graft, repeat the
`process and insert the Chisel to a
`depth of 35mm.
`
`• With the dura protected or minimally
`retracted, the lateral extensions of
`the Cutting Chisel are seated into the
`disc space.
`• Place the lateral edge of the Cutting
`Chisel on or lateral to the mid-
`sagittal line of the pedicle.
`• The Chisel is impacted into the disc
`space. The cutting blades will remove
`the residual osteophytes and create
`an optimal bed to receive the wedge.
`**It is important to note that the depth markings on
`the Chisel are the actual depth of the instrument
`NOT what it is actually cutting. The leading edge
`of the lateral extensions are 5mm. If the Chisel is
`inserted to the 30mm depth mark, the blade of the
`instrument is actually cutting only 25mm of depth.
`
`5
`
`6
`
`

`

`Removal of Cutting Chisels
`
`• After impacting the Cutting Chisel up to a
`depth of 30mm, attach the Slap Hammer to
`the Chisel handle and rotate 90 degrees and
`remove the Chisel with a repeated gentle
`upward stroke.
`
`Cage Insertion
`
`• The implant should be packed with
`bone grafting material either before or
`during this step. Typically, cancellous
`bone taken from the iliac crest is used.
`• The appropriate size cage is firmly
`attached to the Inserter.
`• Gently impact the cage down the
`previously prepared channel until it is
`3 to 4mm below the posterior margin.
`• Care should be taken to ensure the
`cage is aligned properly so that
`it travels down the previously
`created track.
`
`6
`
`7
`
`

`

`Cage Insertion
`
`• Once the cage has been inserted,
`the first Disc Distractor is removed.
`• The second cage is inserted into the
`disc space along the previously
`prepared track.
`
`7
`
`8
`
`

`

`Stabilization
`
`• After the final cage is placed, the extradural space and foramina are probed to ensure adequate
`decompression of the neural elements.
`• To facilitate satisfactory immobilization of the grafted interspace, segmental internal fixation is
`applied using standard technique.
`
`8
`
`9
`
`

`

`MMEEDDTTRROONNIICC ÖÖSSTTEERRRREEIICCHH GGmmbbHH
`Millenium Tower - Handelskai 94-96
`1200 VIENNA - AUSTRIA
`Tel: +43 1 240 44 130 Fax: +43 1 240 44 330
`
`MMEEDDTTRROONNIICC HHEELLLLAASS SS..AA..
`5, Ag Varvaras Str.
`GR15231 HALANDRI, ATHENS - GREECE
`Tel: +30 1 06779099 Fax: +30 1 06779399
`
`MMEEDDTTRROONNIICC PPOOLLAANNDD SSpp.. ZZ..oo..oo..
`Ul. Ostrobramska 101
`04-041 WARSZAWA - POLAND
`Tel: + 48 22 465 69 00 Fax: + 48 22 465 69 17
`
`MMEEDDTTRROONNIICC BBEELLGGIIUUMM
`Boechoutlaan 55
`1853 STROMBEEK-BEVER - BELGIUM
`Tel: +32 2 456 09 00 Fax: +32 2 460 26 67
`
`MMEEDDTTRROONNIICC HHUUNNGGAARRIIAA KKfftt..
`Alkotas Point
`1123 BUDAPEST - ALKOTAS U. 50 - HUNGARY
`Tel: +36 1 889 0600
`Fax: +36 1 889 0699
`
`MMEEDDTTRROONNIICC PPOORRTTUUGGAALL
`Rua Torras da Fonseca Torre - E-8-A/B
`1600-209 LISBOA - PORTUGAL
`Tel: +35 12 17 24 51 00 Fax: +35 12 17 24 51 99
`
`MMEEDDTTRROONNIICC BB..VV..
`Trg Drazena Petrovica 3/V
`10 000 ZAGREB - CROATIA
`Tel: +385 1 48 81 120 Fax: +385 1 48 44 060
`
`MMEEDDTTRROONNIICC CCZZEECCHHIIAA ss..rr..oo..
`Sokolovska 77 - 79
`186 — PRAGUE 8 – CZECH REPUBLIC
`Tel: +49 211 52 93 000 Fax: +49 211 52 93 302
`
`MMEEDDTTRROONNIICC--VVIICCAARREE AA//SS
`Birkeroed Kongevej 150B
`3460 BIRKEROED - DENMARK
`Tel: +45 45 82 33 66 Fax: +45 45 82 33 65
`
`MMEEDDTTRROONNIICC FFIINNLLAANNDD LLTTDD..
`Sahaajankatu 24
`P.O. Box 230
`00811 HELSINKI - FINLAND
`Tel: +35 8 97 55 25 011 Fax: + 35 8 97 75 52 50 18
`
`MMEEDDTTRROONNIICC FFRRAANNCCEE SSAASS
`122, avenue du Général Leclerc
`92514 BOULOGNE BILLANCOURT CEDEX -
`FRANCE
`TEL: +33 1 55 38 17 00 FAX: +33 1 55 38 18 00
`
`MMEEDDTTRROONNIICC GGmmbbHH
`Am Seestern 3
`40547 DUSSELDORF - GERMANY
`Tel: +49 211 52 93 000 Fax: +49 211 52 93 302
`
`MMEEDDTTRROONNIICC IISSRRAAEELL
`World Trade Center
`41, Hameyasdim St.
`40500 EVEN YEHUDA – ISRAEL
`Tel: + 972 9 891 22 23 Fax: +972 9 891 93 20
`
`MMEEDDTTRROONNIICC SSOOUUTTHH AAFFRRIICCAA
`1 Eastgate Lane, Bedfordview
`JOHANNESBURG 2047 - REPUBLIC OF SOUTH
`AFRICA
`Tel: +27 11 677 4800 Fax: +27 11 616 1104
`
`MMEEDDTTRROONNIICC IITTAALLIIAA SS..pp..AA
`Piazza Indro Montanelli, 30
`20099 SESTO SAN GIOVANNI (MI) - ITALY
`Tel: +39 02 241371 Fax: +39.02.24138 223
`
`MMEEDDTTRROONNIICC MMEEDDIITTEERRRRAANNEEAANN SS..AA..LL
`Regional Development Center (RDC)
`St. Charles City Center 6th Floor
`Omar Daouk Street -P.O Box 13.6572
`2020-0908 BEIRUT - LEBANON
`Tel: +961 1 370670 Fax: +961 1 369655
`
`MMEEDDTTRROONNIICC NNEETTHHEERRLLAANNDDSS
`Earl Bakkenstraat 10
`6422 PJ HEERLEN - THE NETHERLANDS
`Tel: +31 45 566 83 62
`Fax: +31 45 566 83 63
`
`MMEEDDTTRROONNIICC VVIINNGGMMEEDD AASS
`Fjordvn. 1. P.O.Box 366
`1323 HOEVIK - NORWAY
`Tel:+ 47 67580680 Fax.: +47 67101212
`
`MMEEDDTTRROONNIICC IIBBEERRIICCAA SS..AA
`C/Calendula, 93 - Edificio «Medtronic G»
`El soto de la Moraleja - Alcobendas
`28109 ALCOBENDAS (MADRID) - SPAIN
`Tel: +34 916 250 500 Fax: +34 916 250 580
`
`MMEEDDTTRROONNIICC SSWWEEDDEENN AABB
`Box 265
`17725 JARFALLA - SWEDEN
`Tel: +46 8 52 22 00 00 Fax: +46 8 52 22 00 50
`
`MMEEDDTTRROONNIICC SSCCHHWWEEIIZZ AAGG
`MMEEDDTTRROONNIICC EEUURROOPPEE
`Route du Molliau, 31 - Case Postale
`CH1131 TOLOCHENAZ - SWITZERLAND
`Tel: +41 21 803 8000 Fax : +41 21 803 8099
`
`MMEEDDTTRROONNIICC LLTTDD
`Suite one- Sherbourne House - Croxley Business
`Center
`WD1 8YE WATFORD - UNITED KINGDOM
`Tel: +44 192 321 22 13 Fax: +44 192 324 10 04
`
`MMEEDDTTRROONNIICC SSOOFFAAMMOORR DDAANNEEKK EEUURROOPPEEAANN SSPPIINNEE CCEENNTTEERR
`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 Bobigny B617 320 486 – NAF 331B
`
`NOT FOR DISTRIBUTION IN THE USA OR ITS TERRITORIES
`
`©2003 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. Patents Pending.
`
`MEUMXTPST03
`
`10
`
`