surgical technique guide

TeCorp
TM
TE LE S C O P I C C O R P ECTO MY SYSTE M
SURGICAL TECHNIQUE GUIDE
FEATURES & BENEFITS
The simplified Vertebral
Body Replacement
Features of Thoraco-Lumbar TeCorp
Modular endplates
3 colour coded endplates
permit 9 possible angular
combinations
Safe support
and anchorage
in the vertebral endplates respect
the adjacent vertebrae
Large graft
areas
improve fusion rate
2
In situ distraction
Secure locking mechanism
allows precise adjustement of the implant height
maintains the distracted implant height
(1mm increment)
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
The titanium TeCorp VBR system implanted via the anterior or anterolateral approach is designed to replace the vertebral
body at the cervical, thoracic or lumbar level.
This VBR system allows the restoration of the intervertebral height as well as lordosis (at the cervical and lumbar level)
and kyphosis (at the thoracic level).
Indications include pathologies which require vertebral reconstruction such as:
• vertebral tumors
• anterior column fractures
Features of Cervical TeCorp
In-built variable cervical endplate
Posterior wall
allows lordosis angulation from 0° to 7°
avoids graft migration
and prevents damage
to the canal and
surrounding tissues
Only two steps
for in situ distraction and locking system
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
3
Surgical protocol for the cervical spine
1 Patient positioning/Anterior approach
The procedure is performed under general anesthesia.
The patient is placed in dorsal decubitus, the approach is
left or right pre-sterno-cleido-mastoid according to
the surgeon’s preference.
2 Discectomy and corpectomy
First, a discectomy above and below the affected area
is performed, followed by a corpectomy using the usual
instruments. According to the pathology, the posterior
longitudinal ligament (PLL) may also be resected
as well as posterior vertebral osteophytes adjacent to
the corpectomy performed.
3 Determining the intervertebral distance
Once the decompression is finished, the measurement
of the intervertebral distance is estimated using
the measuring device.
This will enable implant height to be chosen.
4 Implant choice
Cervical TeCorp device diameter is 16 mm,
different heights are available:
• 20 mm to 25 mm
• 26 mm to 37 mm
• 38 mm to 61 mm
Intervertebral measuring device
20PAC01
4
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
5 Positioning the implant
Before positioning the implant on the parallel distractor
it is important to lock the implant. This secures the implant
on the parallel distractor prior to insertion.
The choosen implant is placed into the space created
by the corpectomy and correctly positioned.
This is important in order to achieve optimal reduction
and stabilization.
The implant is then unlocked with the screwdriver
and distracted in situ.
Distraction is maintained while turning the locking screw.
For precise positioning and reduction of the cervical spine,
the angulation of the upper integrated endplate can be
adjusted in situ.
6 Associated osteosynthesis
It is recommended to add an osteosynthesis plate with
the cervical TeCorp device such as the low profile cervical
Stella plate.
7 Closing the approach
Closure is as usual with suction drainage.
Parallel distractor for cervical
corpectomy implant
20DST01 / 21EDC01
Graft compactor
22COM05
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
Screwdriver for
corpectomy implants
22TRV10
5
Surgical protocol for the thoracic spine
To simplify the surgical technique, we have deliberately
chosen a right thoracotomy.
The lumbar vertebral reconstruction is technically similar
except for the approach which consists in a median
or lateral retroperitoneal postero-lumbar incision.
1 Patient positioning
The procedure is performed under general anaesthesia,
the patient is ventilated with a doublelumen tube.
The patient is placed in left lateral decubitus position,
thus thoracotomy is performed to access the thoracic spine.
2 Discectomy and corpectomy
Lesion level is located, corpectomy is performed using
the usual instrumentation, assuring proper decompression
of the vertebral canal.
6
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
IMPLANTS & INSTRUMENTS
3 Implant choice and modular endplates
Implant choice is determined by the extent and level of
the corpectomy.
A range of implant sizes is available:
Thoracic TeCorp, diameter 21 mm
• 21 mm to 27 mm
• 27 mm to 39 mm
• 39 mm to 63 mm
Lumbar TeCorp, diameter 27 mm
• 28 mm to 40 mm
• 40 mm to 64 mm
Customization of the implant to suit the individual patient
can be achived by the addition of the modular endplates
which can be used in combinations that can create angles
from 0° to 14°.
4 Endplates orientation
According to approach choice, endplates may be oriented
by successive 18º rotations to restore spinal curvature.
18°
36°
54°
0°
5°
7°
Endplate holder for thoracic and
lumbar corpectomy implants
22PRE13
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
Endplates
12PICxx-x
7
5 Positioning the implant
The thoracic TeCorp device is firstly locked before being
placed on the parallel distractor. This secures the implant
on the instrument.
+ Note: In case of a left thoracotomy, the implant must be placed upside
down in order to respect the appropriate position of the posterior wall
protecting the surrounding tissus.
After introduction into the corpectomy space the implant is
unlocked and distracted until correct placement has been
achieved and kyphosis normalised.
Correction may be controlled by direct visualisation
or fluoroscopically.
Distraction is maintained while turning the locking screw
with the screwdriver.
6 Associated osteosynthesis
It is recommended that thoracic and lumbar TeCorp
devices are stabilized with an osteosynthesis system
such as the antero-lateral stabilization Lyra plate.
7 Closing the approach
Closure is as usual with suction drainage.
Parallel distractor for thoracic and
lumbar corpectomy implants
8
20DST01/22EDT01/22EDL01
Graft compactor
22COM05
Please refer to the Instructions For Use document enclosed within product packaging prior to use.
Screwdriver for
corpectomy implants
22TRV10
SCIENT’X
please read carefully
INSTRUCTION FOR USE
Tecorp corporectomy implant
� AIM:
The Tecorp corporectomy implant is an implant designed to replace
the vertebral body. The different sizes of the Tecorp corporectomy
implant allow replacement of the vertebral body in the cervical,
thoracic and lumbar region.
� GENERAL DESCRIPTION:
The Tecorp corporectomy implant allows replacement of the
vertebral body of the segment involved. The device, which is
expandable in situ, permits peroperative distraction of the vertebral
segment involved. Distraction of the implant is performed using a
specific ancillary device that serves both as a prehensor and a
distractor.
For thoracic and lumbar implantation, contact with the overlying and
underlying vertebrae is made via plates, the angulation of which
conforms to the angulation to be restored. The plates are assembled
on the implant peroperatively and several angulations are available.
The upper and lower plates have a notched surface to promote
anchoring with the vertebrae involved.
Tecorp cervical corporectomy implants are equipped with a fixed
upper plate; this plate makes it possible to restore an angulation
peroperatively via a mechanism internal to the implant.
Several sizes are offered to suit the different morphologies.
The Tecorp corporectomy implant is manufactured from
implantable titanium alloy according to ISO 5832-3 or ASTM-F 136
standards.
The Tecorp corporectomy implant must not be used with
components derived from other manufacturers.
� INDICATIONS:
The corporectomy implant is a surgical implant that allows
reconstruction of the intervertebral space via the anterior approach.
The indications include:
Vertebral body tumours,
Fracture of the anterior spine,
Vertebral reconstruction following monosegmental or
multisegmental corporectomy.
� CONTRAINDICATIONS:
The contraindications of the Tecorp corporectomy implant include:
- local infection or inflammation,
- vertebral osteoporosis,
- allergy to or intolerance of titanium or its alloys,
- incompatible age and physical condition of the patient,
- any case not included in the indications.
The Tecorp corporectomy implant is not designed, intended or sold
for any uses other than those indicated.
� POSSIBLE ADVERSE EVENTS:
- infection,
- secondary collapse,
- loss of correction,
- intolerance of the material.
Note: an additional surgical operation may be necessary in order to
correct an adverse event.
Warnings: an entirely satisfactory result is not always systematically
obtained with each surgical operation. This applies particularly to
spinal surgery in which many external elements may compromise the
results.
� S URGICAL PRECAUTIONS:
The surgeon must be perfectly acquainted with the Tecorp
corporectomy device, the application method, instruments and
surgical technique.
The size of the Tecorp corporectomy implant must be chosen
according to the clinical case and the desired correction. The
angulation of the plates must be selected according to the segmental
angulation that one is endeavouring to restore.
Before implantation of the Tecorp corporectomy implant, the end
plates must be carefully curetted and refreshed without being
weakened in order to avoid risks of collapse of the implant.
The Tecorp corporectomy implant must be filled with autologous,
allogenic bone, cement or a bone substitute in order to achieve bone
fusion.
It is imperative to combine the Tecorp corporectomy implant with
an anterior or anterolateral and/or posterior fixation system.
A control X-ray allows confirmation of correct positioning of the
implant in relation to the vertebrae.
DOREG103 en
1/1
Before implantation, the batch number and reference of the
Tecorp corporectomy implant inserted must be systematically
recorded in the patient’s surgical file.
. This product is a single use device. Under no circumstances
should it be reused. While the device may appear to be undamaged, it
may have small defects or internal stress patterns, as a result of the
prior implantation or removal that could lead to fatigue failure.
Additionally, please note that the removed implant has not been
designed or validated so as to allow for decontamination of
microorganisms. Reuse of this product could lead to cross-infection
and/or material degradation as a result of the decontamination
process. The company accepts no responsibility for products which
have been reused.
• Attention: no silicone, formaldehyde or latex based products should be
implanted with a SCIENT’X implant
� PACKAGING:
The Tecorp corporectomy implants and their accompanying
ancillary instruments are supplied in a single container, a “kit”, except
for kit restocking at the warehouse. The kit must be closed and sealed;
its packaging must be intact on receipt. If the warehouse kit system is
used, the complete composition of the kit must be carefully checked.
The storage conditions must make it possible to maintain intactness of
the implants, the associated ancillary devices and their respective
packaging.
Good condition of all the implants and instruments must be controlled
before any use. Damaged products must not be used and must be
returned to SCIENT’X.
■ DECONTAMINATION, CLEANING AND STERILIZATION:
Products delivered in sachets are not sterile.
For implants delivered sterile: the implants are sterilized by
Gamma radiation at doses of 25 to 40 kGy. The expiry date is 5 years.
The expiry date of sterile parts is indicated on the packaging. Resterilization of implants delivered sterile is prohibited.
For implants and instruments not sterile on delivery: all implants
and instruments delivered non-sterile must be decontaminated,
cleaned and sterilized before and after use. Implants and
instruments in sachets must be removed from the original packaging
for the following operations:
Recommended method:
- Decontamination: Plunge the implants and instruments into a
bactericidal and fungicidal solution of the didecyldimethylammonium
chloride type diluted to 0.5 % (5mL to 1 litre water). Length of
soaking: 20 min. Rinse with demineralized water.
- Cleaning: Wash the implants and instruments in a LANCER type
machine with suitable cleaning products, rinse and dry. Any product
that might damage the equipment is forbidden (such as bleach,
formol, etc.).
Sterilization: It is essential to sterilise the kit by steam using the
following conditions:
Ø pre-heating for 25’ at 110° (1 bar)
Ø vacuum 5' (0.8 bar under atmospheric pressure)
Ø heating 5' at 120° (1 bar)
Ø vacuum 5' (0.8 bar)
Ø sterilization 18' at 134° (2 bars)
Ø drying 20' return to room temperature
■COMPLAINTS:
Any complaints, together with the reference and lot number of the
incriminated product, should be sent to Scient’x.
� ADDITIONAL INFORMATION:
For any additional information, please contact:
SCIENT’X
22, rue Jean Bart
78960 Voisins le Bretonneux - FRANCE
tel.: 33 (0)1 39 30 69 30
fax: 33 (0)1 30 43 82 77
e-mail: [email protected]
0459 2002
Last revision: 06/2010
Do not
useuse
if if
Do
not
package is is
package
damaged
damaged
Non
Nonsterile
sterile
Manufacturer
Manufactu
rer
Do
Donot
re-use
not
reuse
Sterile
Steril
e
ReadIFU
IFU
Read
Date
Date
of of
Manufacture
manufa
cture
Useonly
Use
only
Date d'application : 21/02/2011
Revision :1.0
DMQ#11-106
Implants
Corpectomy implants
Color
code
Cervical implant
Ø 16 mm
gold
Thoracic implant
Ø 21 mm
green
Lumbar implant
Ø 27 mm
blue
Height
(mm)
Ref.
from 20 to 25
from 26 to 37
from 38 to 64
from 21 to 27
from 27 to 39
from 39 to 63
from 28 to 40
from 40 to 64
11ICC16-20
11ICC16-26
11ICC16-38
12ICT21-24
12ICT21-30
12ICT21-42
12ICT27-31
12ICT27-43
Endplates
For thoracic
implant
For lumbar
implant
Color
code
Angle
Maximum
height (mm)
Ref.
purple
gold
silver
purple
gold
silver
7°
5°
0°
7°
5°
0°
3.6
2.8
1
4.3
3.4
1
12PIC21-7
12PIC21-5
12PIC21-0
12PIC27-7
12PIC27-5
12PIC27-0
Instruments
Ref.
Parallel distractor for corpectomy implants
Cervical tips for parallel distractor
Thoracic tips for parallel distractor
Lumbar tips for parallel distractor
Endplate holder for thoracic and lumbar corpectomy implants
Graft compactor
Intervertebral measuring device
Screwdriver for corpectomy implants
Screwdriver for cervical corpectomy implants
20DST01
21EDC01
22EDT01
22EDL01
22PRE13
22COM05
20PAC01
22TRV10
21TRV08*
* On request. Delivery time to be confirmed with order.
11
Corporate Headquarter:
ALPHATEC SPINE, INC.
5818 El Camino Real
Carlsbad, CA 92008 - U.S.A.
TL +1 460 431 9286
www.alphatecspine.com
International Headquarter:
SCIENT’X-ALPHATEC SPINE
22, avenue Jean Bart
78960 Voisins-le-Bretonneux - FRANCE
TL +33 (0)1 39 30 69 30 - FX +33 (0)1 30 43 82 77
www.scientx.com
This product is not available for sale in the United States of America.
Non contractual pictures.
Please read carefully the instructions for use bulletin.
Devices may be subject to modification. Patented.
TeCorp & Scient’x-Alphatec Spine logo are trademarks of Alphatec Spine, Inc. (C) 2011 Alphatec Spine, Inc. All rights reserved.
DOMKT507 en Rev1.0 - DMQ#11-315 - Approval date: August 2011