B.Braun Aesculap Spine B4 Mode D'emploi

Aesculap Spine
Instructions for use
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S Spinal System - Lumbar/Deformity
Instructions for use
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S Spinal System - Lumbar/Deformity
Note for U.S. users
U.S. cleared device instructions for use can be found at
www.aesculapimplantsystems.com "Products & Services". If you
do not have internet access please call your local Aesculap repre-
sentative or customer service at 1-800-258-1946.
Gebrauchsanweisung
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S Spinal System - Lumbar/Deformity
Mode d'emploi
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S Spinal System - Lumbar/Deformity
Instrucciones de manejo
Gerätebezeichnung
Istruzioni per l'uso
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S Spinal System - Lumbar/Deformity
Instruções de utilização
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S Spinal System - Lumbar/Deformity
Gebruiksaanwijzing
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S Spinal System - Lumbar/Deformity
Návod k použití
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S Spinal System - Lumbar/Deformity
Aesculap AG & Co. KG
Am Aesculap-Platz
78532 Tuttlingen
Germany
Phone +49 7461 95-0
Fax +49 7461 95-2600
www.aesculap.de
TA-Nr. 011187 09/07 Änd.-Nr. 31319
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/EHS
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
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S Spinal System - Lumbar/Deformity
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
• 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
Risk of broken screws if pedicle screws are used
when performing spondylolisthesis!
Support the stabilization measure with an
intercorporal fusion (ALIF, PLIF or TLIF).
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 sys-
tems
• 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 compo-
nents 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 tech-
niques.
• It is the operating surgeon's responsibility to ensure the correct combina-
tion 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 train-
ing, 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.
Processing
Implants supplied in unsterile condition have been cleaned by the manufac-
turer through a process appropriate for the hospital and are protected by the
product packaging to the extent that, prior to the application of the product,
the following pre-sterilization cleaning process is sufficient:
– Ultrasonic cleaning in VD-water immersion bath
– Final rinse under running VD water
– Drying with clean compressed air (oil-water separator)
In contrast to reusable medical products, e.g. surgical instruments, implants
must not be reprocessed once they have been contaminated with blood
(direct or indirect contamination).
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.
Implants must be pre-cleaned and steam-sterilized prior to application.
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 ISO 17665 or EN 554/ISO 13683). In case of application of the frac-
tionated vacuum procedure the sterilization has to be done using the
134 °C/2 bar program 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 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
• Those performing operations must be thoroughly conversant with the
rules governing medical practice, the current state of scientific knowl-
edge, 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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Spinal
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Spinal System implant