B.Braun Aesculap Spine S4 Mode D'emploi page 2

®
Aesculap
4®
S Spinal System – Augmentation Screw
Note
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Generally, the S Spinal System – augmentation screw is covered by the instructions for use of the S
Lumbar/Deformity TA011187. This information on the augmentation screw is intended to complement the respective
information contained in the instructions for use of the S
Symbols on product and packages
Sterilization using irradiation
Not for reuse in intended applications as defined by the manufacturer
Use by
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
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The S Spinal System implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar
and thoracic spine.
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The injection cannula is inserted in the S Spinal System - augmentation screw to apply bone cement.
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The S Spinal System - augmentation screw comprises:
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Monoaxial/ polyaxial screws (augmentation screw), supplied in sterile condition
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Cement injection cannula (sterile), see TA013132
Note
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There are special S instruments provided for the implantation of these system components and for the augmentation,
distraction, compression, and reduction of the lumbar and thoracic spine.
Materials
The materials used in the implant are listed on the packaging:
■
ISOTAN® Titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
■
ISOTAN® Pure titanium acc. to ISO 5832-2
P
The titanium implants are coated with a colored oxide. Slight changes in coloration may occur, but do not affect the
implant quality.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.
Indications
Surgically installed implants are designed to support the normal healing process. They are not intended for use either
as replacements for natural body parts or to bear loads over the long term if healing does not occur.
Use for:
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Fractures
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Pseudarthrosis or delayed healing
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Dislocation
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Degenerative instability
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Post-discectomy syndrome
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Spondylolisthesis
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Kyphosis
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Scoliosis
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Stenosis
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Post-trauma instability
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Tumors
Risk of screw breakage caused by pedicle screws used for spondylolisthesis!
►
Support the stabilization measure with interbody fusion (ALIF, PLIF or TLIF).
WARNING
Contraindications
Do not use in the presence of:
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Fever
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Acute or chronic vertebral infections of a local or systemic nature
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Pregnancy
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Severe osteoporosis or osteopenia
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Medical or surgical conditions that could negatively affect the outcome of the implantation
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Mental illness
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Dependency on pharmaceutical drugs, drug abuse, or alcoholism
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Adiposity
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Severely damaged bone structures that could prevent stable implantation of implant components
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Neuromuscular disorders or illnesses
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Bone tumors in the region of implant fixation
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Wound healing disorders
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Inadequate patient compliance
■
Foreign body sensitivity to the implant materials
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Cases not listed under indications
Note
In cases of osteopenia, the surgeon must weigh up the possible risks that could endanger the therapeutic success of
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the S Spinal Systems. If reduced hold of the S
System – augmentation screw can be used. The S
to increase anchoring stability. The directions for use of the associated cement application system must be complied
with.
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Spinal System - Lumbar/Deformity.
4
Spinal System – augmentation screw is expected, the S
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Spinal System – augmentation screw can be fixed with bone cement
Side effects and interactions
The application or improper use of this system entails the following risks:
■
Implant failure resulting from excessive load
– Warping or bending
– Loosening
– Breakage
■
Inadequate fixation
■
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Spinal System –
Failed or delayed fusion
■
Cement leakages (cement emerging from the vertebral body)
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Infection
■
Fractured vertebral body or bodies
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Injuries to
– nerve roots
– spinal cord
– blood vessels
– organs
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Changes of the normal spine lordosis
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Impairment of the gastrointestinal, urological, and/or reproductive systems
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Pain or indisposition
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Bursitis
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Decreased bone density due to load avoidance
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Bone atrophy/fracture above or below the spine section provided for
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Limited physical ability
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Persistence of symptoms that were to be treated by the implantation
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Death
Safety notes
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
■
It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
■
General risk factors associated with surgical procedures are not described in this documentation.
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The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
■
The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
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The operating surgeon is responsible for combining and implanting the implant components, with or without
bone cement.
■
Aesculap is not responsible for any complications arising from erroneous indication, wrong choice of implant,
incorrect combination of implant components and operating technique, the limitations of the treatment method,
or inadequate asepsis.
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The user must follow the instructions that accompany each of the Aesculap implant components.
■
The implant components were tested and approved in combination with Aesculap components. If other combi-
nations are used, the responsibility for such action lies with the operating surgeon.
■
Do not, under any circumstances, combine implant components from different manufacturers.
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Do not, under any circumstances, use damaged or surgically excised components.
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Implants already used must not be used again.
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Do not use instruments belonging to another system or made by another manufacturer.
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Delayed healing can cause implant breakage due to metal fatigue.
■
The surgeon in charge of the therapy shall make any decision with regard to the removal of implant components
that have been used.
■
Damage to the weight-bearing bone cement and/or bone structures can cause loosening of the components,
fracture of the bone or implant and other grave complications.
■
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.
■
Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
Sterility
■
The implant components come individually packed in protective packaging that is labeled according to its con-
tents.
■
The implant components are gamma-sterilized.
►
Store implant components in their original packaging. Remove them from their original protective packaging
only just prior to application.
►
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 expiration date or whose packaging is damaged.
WARNING
Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
■
Selection of the implant components and their dimensions
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Positioning of the implant components in the bone
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Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
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All requisite implant components are ready to hand
■
Operating conditions are highly aseptic
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The implantation instruments, including the special Aesculap implant system instruments, are complete and in
working condition.
■
The operating surgeon and operating room team are thoroughly conversant with the operating technique and
with the available range of implants and instruments; information materials on these subjects must be complete
and ready to hand.
■
The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
■
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Spinal
The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
Interactions between MRI and implant components!
■
MRI examinations using magnetic fields of 1.5 and 3.0 tesla do not present an
additional risk to implant wearers.
■
MRI causes non-critical, localized heat development.
■
Implants produce moderate MRI artifacts.
Damage to implants caused by processing and resterilization!
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Do not reprocess or resterilize the implants.