B.Braun Aesculap Spine S4 Mode D'emploi

Aesculap Spine
4
S Spinal System - Lumbar/Deformity
Instructions for use
Instructions for use
Note for U.S. users
U.S. cleared device instructions for use can be found at
www.aesculapusa.com "Products & Services".
If you do not have internet access please call your local
Aesculap representative or customer service
at 1-800-258-1946.
Gebrauchsanweisung
Mode d'emploi
Instrucciones de manejo
Istruzioni per l'uso
Instruções de utilização
Gebruiksaanwijzing
Návod k použití
CE marking according to directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/EWG
Marquage CE conforme à la directive 93/42/CEE
Identificación CE en conformidad con la directriz 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE
Simbolo CE, em conformeidade com a Directiva 93/42/CEE
CE-certificering conform richtlijn 93/42/EEG
CE-oznaèení podle smìrnice 93/42/ES
Technical alterations reserved
Technische Änderungen vorbehalten
Sous réserve de modifications techniques
Sujeto a modificaciones técnicas
Con riserva di modifiche tecniche
Salvo alterações técnicas
Technische wijzigingen voorbehouden
Technické zmìny vyhrazeny
Aesculap AG & Co. KG
Am Aesculap-Platz
78532 Tuttlingen
Phone +49 74 61 95-0
Fax +49 74 61 95-2600
www.aesculap.de
TA-Nr. 011187
S
Intended use
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The S Spinal System implants are used for the dorsal monosegmental and
multisegmental stabilization of the lumbar and thoracic spine.
System components
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The S Spinal System consists of:
• Mono/polyaxial screws
• Rods
• Hooks
• Transverse connectors
• Sacral discs
• Appropriate fixation elements
Specialized instruments must be used for the implantation of these compo-
nents, as well as for the distraction, compression and repositioning of lumbar
and thoracic vertebrae.
Materials
The materials used in the implant are listed on the package.
• Titanium forge alloy Ti6Al4V according to ASTM F 136 and ISO 5832-3
• Pure titanium according to ASTM F 67 or ISO 5832-2
Indications
The purpose of implants performed intraoperatively is to support the normal
healing process. They are not intended to replace normal body structures or
as permanent support for loads occurring in cases where healing does not
take place or is delayed.
Use for the following indications:
• Fractures
• Pseudarthrosis or delayed healing
• Dislocation
• Degenerative instability
• Post-discectomy syndrome
• Spondylolisthesis
• Kyphosis
• Scoliosis
• Stenosis
• Post-trauma instability
• Tumors
WARNING
Contraindications
Do not apply in the presence of:
• Fever
• Acute or chronic vertebral infections of a local or systemic nature
• Pregnancy
• Severe osteoporosis or osteopenia
• Medical or surgical conditions that could negatively impact the success
of the implantation
• Mental illness
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Adiposity
• Severely damaged bone structures that could prevent stable implantation
of implant components
• Neuromuscular disorders or illnesses
• Bone tumor in the region of implant fixation
• Wound healing disorders
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
• Cases not listed under indications
Side-effects and adverse interactions
The application or improper use of this system carries the following risks:
• Implant failure resulting from excess load
– warping or bending
– loosening
– breakage
• Inadequate fixation
• Absence of, or delayed, bony union
• Infection
• Fractured vertebral body or bodies
• Tissue reaction to implant materials
• Hematoma and impaired wound healing
• Injuries to
– nerve roots
– spinal cord
– vessels
– organs
• Changes of the normal spine lordosis
• Impairment of the gastrointestinal, urological and/or reproductive
systems
• Pain or indisposition
• Bursitis
• Decreased bone density due to load avoidance
• Bone atrophy/fracture above or below the spine section provided for
• Limited performance
• Persistence of symptoms that were to be treated by the implantation
• Death
Safety information
General risk factors associated with surgical procedures are not described in
this documentation.
• It is the operating surgeon's responsibility to ensure that implant
components are applied correctly during operative procedures.
• The operating surgeon must have a thorough command of both the hands-
on and conceptual aspects of the established operating techniques.
• It is the operating surgeon's responsibility to ensure the correct
combination of implant components and their implantation.
• 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
and instruments must be observed.
• Under no circumstances may modular implant components from different
suppliers be combined.
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• The S Spinal System implants must only be implanted using the S
System special instruments.
• Under no circumstances should damaged components or surgically
excised components be used.
• Implants once used must not be reused.
• 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
training, it is of particular importance that the physician keep the patient
well informed.
• Damage to load-bearing bone structures can result in loosening of the
components, bone or implant fractures or other acute complications.
• To ensure the earliest possible detection of such causes of dysfunction,
the implant must be checked periodically, using appropriate techniques.
• Delayed healing can cause implant components to fracture as a result of
metal fatigue.
• The physician in charge decides whether the S
ought to be removed.
Sterility
• The implant components are delivered unsterile.
• The implant components are delivered in individual packaging.
!
Store implant components in their original packaging and only remove
them from such packaging immediately befor use.
!
Prior to use, preclean and steam sterilize implants in accordance with
applicable hospital guidelines for the preparation of sterile materials.
02/05 Änd.-Nr. 28271
4
Spinal System - Lumbar/Deformity
Risk of broken screws if pedicle screws are used when per-
forming spondylolisthesis!
!
Support the stabilization measure with an intercorpo-
ral fusion (ALIF, PLIF or TLIF).
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Spinal System implant
Sterilization method and parameters
!
Use the implant system storage trays for sterilization and sterile prepa-
ration.
!
Sterilize with steam, taking note of the following:
The sterilization has to be done according to a validated steam steriliza-
tion procedure (e.g. in a sterilizer according to EN285/ANSI/AAMI/
ISO11134-1993, ANSI/AAMI ST46-1993 and validated according to
EN 554/ISO 13683). In case of application of the fractionated vacuum
procedure the sterilization has to be done using the 134 °C/2 bar pro-
gram with a minimal holding time of 5 minutes.
Application
The operating surgeon shall devise an operation plan that specifies and
accurately 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
• The implantation instruments, including the special Aesculap implant
system instruments, must be complete and in working condition
• The operating surgeon and operating room team must be thoroughly
conversant 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
• Those performing operations must be thoroughly conversant with the
rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant articles by medical specialists
from the professional literature
• In case of an ambiguous preoperative situation and if an implant is
already present in the region to be provided for, information was sought
from the manufacturer.
The operative procedure has been explained to the patient, and the latter's
understanding of the following information has been documented:
• Delayed healing or incomplete fusion can cause the implant to fracture or
loosen as a result of the extreme load to which it is subjected.
• Smokers present an increased risk of fusion failure.
• The life-span of the implant is determined by body weight.
• Implant components must not be subject to extreme load arising from
sports activities or strenuous physical work.
• If the implant becomes loose, fractures or deviates from its correction
position, a revision operation must be performed.
• The patient must undergo a regular medical follow-up examination of his/
her implant components.
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For implanting the S Spinal System implant, the following steps need to be
carried out:
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Select the appropriate S Spinal System variant and anchoring implants
according to indication, preoperative planning and bone situation found
intraoperatively.
! 4
When choosing the S Spinal System screw types, make certain to select
the correct diameter, length and canal orientation.
Trauma to the spinal column and nerve roots due to incorrect
application!
!
Position instruments and insert pedicle and polyaxial
screw only with the aid of a radiographic visualization
WARNING
or navigation system.
!
To avoid internal stress on, and weakening of, the implant: avoid scoring
or scratching of the implant components.
!
Do not change the shape of any metal implants except for the rods and
transverse connectors of the Aesculap S
!
Do not bend back, or bend excessively, the rods and transverse connec-
tors.
!
Always use bending instruments of the S
for bending the rods and transverse connectors.
!
For positioning the clamping screw, always use the clamping screw
insertion instrument intended for this purpose.
!
For tightening and loosening the clamping screw, always use the screw-
driver and countering instrument intended for this purpose.
!
Always tighten the clamping screws with the torque wrench intended for
this purpose.
Risk of injury due to improper mounting of the clamping
screw!
!
Set the clamping screw in place correctly.
!
Make certain that rods are correctly positioned on the
WARNING
floor of the groove.
!
Fully tighten the clamping screw, using the torque
wrench.
!
Break off the flanks only when the clamping screws
have been fully tightened.
Correction loss due to insufficient fixation of the polyaxial
head!
!
Never loosen the connection of the polyaxial head
again, once it has been tightened.
WARNING
!
Tighten the clamping screw only after every necessary
correction measure has been performed.
Damage to the implant caused by overtightening of the
clamping screw!
!
Always tighten the clamping screw with the exact
torque specified for this purpose.
WARNING
Screw head expansion caused by tightening of the clamping
screw without using the countering instrument!
!
Always use the countering instrument when tightening
the clamping screw.
WARNING
Damage to the implant caused by applying the repositioning
instruments too high at the implant!
!
Always apply repositioning instruments (e. g. distrac-
tion and compression forceps) below the rod at the im-
WARNING
plant.
Screw head expansion caused by derotation without using
derotation sleeves!
!
Always use derotation sleeves for rod derotation.
WARNING
Damage to the implant caused by spondylolisthesis reposition
through the clamping screw!
!
Always use the rod persuader for spondylolisthesis
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reposition.
Spinal
WARNING
!
Always use the special flank breaking forceps for breaking off the flanks.
!
If the 8-mm polyaxial screw loosens during revision, remove the remain-
ing screw component with the screwdriver SW 3.5.
!
When using a clamp (hook, counter hook and connecting pin), use special
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S Spinal System mounting instruments.
Risk of injury due to inadequately tightened counterhook
clamping screw!
!
Make sure that the pin is correctly positioned on the
floor of the groove.
WARNING
!
Make sure that the counterhook clamping screw is well
tightened.
!
For tightening the locking screws of the cross connector, always use the
torque wrench and countering instrument intended for this purpose.
Further information about Aesculap implant systems is available from
Aesculap or the Aesculap office responsible.
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Spinal System.
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Spinal System instrument set