B.Braun Aesculap Spine activ L Mode D'emploi page 2

activ L intervertebral disc
prosthesis
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Intended use
The activ L intervertebral disc prosthesis is used for replacing intervertebral
discs in the lumbar spine. They restore the disc height and the segmental
mobility.
They comprise:
• inferior and superior prosthesis plates for anchoring in the vertebral
bodies
– in sizes S, M, L and XL
– with a central anchoring fin
(can only be implanted through anterior access)
- or -
without a central anchoring fin
(for implantation through anterior or lateral (approx. 45°) access)
• a polyethylene inlay, which is inserted into the inferior prosthesis plate
– for total heights of 8.5 mm, 10 mm, 12 mm and 14 mm
– to be combined with any plate size
The prosthesis plates and the polyethylene inlay together form a ball joint.
The operating surgeon chooses, according to the anatomic conditions,
between using prosthesis plates with anchoring fin and prosthesis plates
without such a fin.
Materials
The materials used in the implant are listed on the packaging:
• ISODUR® Cobalt-Chromium wrought alloy CoCr29Mo acc. to ISO 5832-
F
12
• PLASMAPORE® surface coating made of pure titanium acc. to
µ-CaP
ISO 5832-2, with an additional calcium phosphate coating
• Ultra-high molecular low-pressure polyethylene acc. to ISO 5834-2
ISODUR® and PLASMAPORE® are registered trademarks of Aesculap AG,
78532 Tuttlingen / Germany.
Indications
Lumbar discopathy
Detailed definition: Monosegmental or bisegmental disc degeneration
between L3 and S1. No existing significant degeneration of the facet joints.
No existing degeneration, or only minor degeneration, of the discs adjacent
to the segments to be treated, and no existing posterior instability. Preoper-
ative disc height of at least 3-4 mm.
Contraindications
Do not apply in the presence of:
• Fever
• Infection: acute, systemic, in the spine, local
• Systemic diseases and metabolic disorders
• Pregnancy
• Osteoporosis, osteochondrosis, severe osteopenia
• Any medical condition that could preclude the success of the implanta-
tion
• Spinal stenosis, radiculopathy
• Degenerated facets
• Increased segmental instability
• Vertebral body fracture
• Spinal deformity
• Spondylolisthesis above 25 %
• Pharmaceutical or other drug abuse; alcoholism
• Obese or overweight patients
• Foreign body sensitivity to the implant materials
• Inadequate patient compliance
• All cases that are not listed under indications
Side-effects or adverse interactions
• Bent, loose, worn or broken implant components
• Loss of fixation, dislocation and migration
• Infections
• Allergic reactions to implant materials
• Tissue reaction to implant materials
• Venous thrombosis, lung embolism, and cardiac arrest
• Hematomas and wound healing disorders
• Periarticular calcifications and fusions
• Injuries to: nerve roots, spinal cord, blood vessels, organs
Safety information
• The implant components were tested and approved for use in combina-
tion with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
• It is the operating surgeon's responsibility to ensure that the operative
procedure is performed properly.
• General risk factors associated with surgical procedures are not described
in the present documentation.
• The operating surgeon must have a thorough command of both the
hands-on and conceptual aspects of the established operating tech-
niques.
• The operating surgeon must be thoroughly familiar with bone anatomy,
including the pathways of nerves, blood vessels, muscles and tendons.
• Aesculap is not responsible for any complications arising from incorrect
diagnosis, choice of incorrect implant, incorrectly combined implant
components and/or operating techniques, the limitations of treatment
methods, or inadequate asepsis.
• The instructions for use of the individual Aesculap implant components
must be observed.
• Under no circumstances may modular implant components from different
suppliers be combined.
• Under no circumstances should damaged components or surgically
excised components be used.
• Implants that have already been used must not be reused.
• The physician in charge decides whether an implant component
implanted should be removed, taking into account the potential risks of
another operation and the difficulties involved in the removal of an
implant.
• The implant components applied, along with their article numbers, the
name of the implant, as well as the batch number and serial number (if
available) must be documented in all patient records.
• During the postoperative phase, in addition to mobility and muscle train-
ing, it is of particular importance that the physician keep the patient well
informed.
• Damage to the load-bearing structures of the implant may cause the
loosening of components, their dislocation and migration, and other
severe complications.
• To ensure the earliest possible detection of such factors favoring implant
malfunction, the activ L intervertebral disc prosthesis must be inspected
postoperatively, on a regular basis, by suitable procedures.
Sterility
• The implant components come individually packed in protective packag-
ing that is labeled according to its contents.
• The implant components have been sterilized by irradiation (min. dose
25 kGy).
• The implant components must not be resterilized.
Store the implant components in their original packaging. Do not remove
them from their original and protective packaging until immediately
before using them.
Prior to use, check the product expiry date and verify the integrity of the
sterile packaging. Do not use implant components that are past their
expiry date or whose packaging is damaged.
Application
The operating surgeon shall devise an operation plan that specifies and accu-
rately documents the following:
• Selection of the implant components and their dimensions
• Positioning of the implant components in the bones
• Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
• All requisite implant components must be ready to hand
• Operating conditions must be highly aseptic
• Implantation instruments including the special Aesculap implant system
instruments are complete and in working condition
• The operating surgeon and operating room team must be thoroughly con-
versant with the operating technique, as well as the range of implants
and instruments to be applied; complete information on these subjects
must be readily available at the workplace.
• The operating surgeon must be familiar with the rules governing medical
practice, the current state of scientific knowledge, and the contents of
relevant articles by medical specialists from professional literature.
• The manufacturer has been consulted if the preoperative situation was
unclear and if implants were found in the area operated on.
The operative procedure has been explained to the patient, and the latter's
understanding of the following information has been documented:
• The patient is aware of the risks involved in neurosurgery, general surgery,
orthopedics and general anesthesia.
• The patient has been informed of the advantages and drawbacks of an
activ L intervertebral disc prosthesis, and has been made aware of possi-
ble alternative therapeutic methods.
• Excessive load, wear or infection can lead to malfunctions of the activ L
intervertebral disc prosthesis.
• The life-span of the implant depends on the patient's body weight.
• The activ L intervertebral disc prosthesis must not be subjected to exces-
sive strains through extreme loads, hard physical labor or sports activities.
• Implant failure may necessitate revision surgery.
• If revision surgery is carried out, it may not be possible to preserve the
segmental movement.
• The patient must undergo regular medical check-ups of the activ L inter-
vertebral disc prosthesis.
• Only use instruments intended for Aesculap activ L intervertebral disc
prostheses.
• Observe the instructions for use of insertion instrument TA011458, dis-
tractor TA011540 and distraction forceps revision instrument TA011904.
• Observe the OR manual O27901.
• Select implant components according to the indication, preoperative
planning and the bone situation found intraoperatively.
• The height printed on the packaging of the polyethylene inlay is equiva-
lent to the total posterior height of the disc prosthesis, i. e. of the inferior
prosthesis plate, the polyethylene inlay and the superior prosthesis plate.
The final height of the polyethylene inlay is determined intraoperatively,
in most cases.
Preoperative planning
Risk of incorrect size selection due to using an X-
ray template of the wrong scale!
Make certain to choose an X-ray template of
the correct scale.
WARNING
Carry out preoperative planning, using X-ray templates.
Increased risk of migration caused by selecting a
prosthesis plate that is too small!
The prosthesis plate must completely cover
the end plate of the vertebral body.
WARNING
Select the size of the prosthesis plate so that maximum coverage of the
vertebral bodies is achieved.
Surgical access
Risk of damage to blood vessels and nerves
caused by sharp instruments!
Operate with extreme caution to avoid dam-
age to blood vessels, nerves or tissue.
WARNING
Have a vascular surgeon assisting or on call.
Establish the surgical access to the affected segment.
Note
Prosthesis plates with an anchoring fin can only be implanted through ante-
rior access. Prosthesis plates without an anchoring fin can also be implanted
through lateral access (approx. 45°).
Marking the midline
Mispositioning of the vertebral disc prosthesis
caused by inaccurate marking of the midline!
Always mark the midline under X-ray con-
trol.
WARNING
Make certain to use a midline marker of the
correct size when installing the lateral
access.
Determine the center of the vertebral disc, using the midline marker,
under X-ray control.
Apply markings on the superior and inferior vertebral bodies.
When operating through an anterior access, use the anterior midline
marker.
When operating through a lateral access, use the lateral midline marker
of the appropriate size.
Discectomy and preparation of the vertebral body end plates
Insufficient anchoring stability due to incomplete
removal of cartilage!
Remove the cartilage layer from the verte-
bral body end plates.
WARNING
Increased risk of migration due to over-prepara-
tion of the vertebral body endplates!
Avoid any aggressive preparation of the ver-
tebral body end plates.
WARNING
Do not remove the vertebral body end plates
completely.
Completely remove the intervertebral disc, using standard instruments.
Remove all cartilage from the vertebral body end plates.
Verifying the size and distraction
Mount the trial plates of the selected size on the distractor in such a way
that the marking for the lateral/anterior access corresponds to the mark-
ing on the working tip of the distractor.
Compression of the spinal canal and of other pos-
terior elements caused by the distractor inserted
too deeply!
Introduce the distractor into the interverte-
WARNING bral space under X-ray control.
On the X-ray image, under AP and lateral
irradiation, check to ensure that the size,
position and alignment of the trial plates are
correct.
Cautiously introduce the undistracted distractor into the intervertebral
space, making sure that it is positioned centrally.
Check the size of the vertebral body end plates. A margin of 1 mm to
2 mm width is allowed between the lateral and posterior edges of the trial
plates and the edge of the vertebral body.
Irritation of the facet joints and strain on dura
and nerve roots due to excessive or insufficient
distraction!
Distract only to such an extent that the
WARNING instrument firmly fits in the intervertebral
space.
On the X-ray image, under AP and lateral
irradiation, check to ensure that the size,
position and alignment of the trial plates are
correct.
Open the distractor until it is firmly seated in the intervertebral space.
Read the distraction height on the distractor scale.
If the mark is between to height values on the scale, choose the lower
height.
Release the distraction and remove the distractor from the intervertebral
space.
If necessary, use a small spacer for keeping the vertebral bodies apart.
Chiseling out the anchoring for prosthesis plates with anchoring fin
The chiseling procedure will determine the central position and the alignment
of intervertebral disc prosthesis in the intervertebral disc plane.
The chisel depth is defined by the bedstop of the chisel on the chisel guide.
Mount the chisel guide of the selected height on the handle.
Turn the adjusting wheel of the depth bedstop to adjust it to the mini-
mum insertion depth.
Mispositioning of the intervertebral disc prosthe-
sis due to failure to align the chisel guide with
the midline!
Align the chisel guide with the midline mark.
WARNING
Make certain that the position of the chisel
guide does not change during the chiseling
procedure.
Compression of the spinal canal and of other pos-
terior elements caused by the chisel guide
inserted too deeply!
Prior to insertion, adjust the chisel guide to
WARNING the minimum insertions depth.
Introduce the chisel guide into the interver-
tebral space under X-ray control.
Insert the chisel guide into the intervertebral space under X-ray control.
Align the groove on the chisel guide with the midline marks.
If necessary, readjust the depth bedstop until the posterior edge of the
chisel guide is at the height of the posterior edge of the vertebral body,
or 1 mm to 2 mm in front of it.
Check to ensure that the chisel guide is firmly seated.
Choose a different height or angle variant, if necessary.
Dismount the handle from the chisel guide.
Risk of injury caused by sharp chisel!
Apply the chisel with extreme caution to
avoid damage to critical blood vessels, nerves
or other tissue, as well as injury to yourself.
CAUTION
Carefully slide the chisel over the shaft of the chisel guide, until it
engages in the guide groove.