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

en
®
Aesculap
4®
S Spinal System – Sterile-packaged
Symbols on product and packages
Sterilization using irradiation
Not for reuse as per the manufacturer-defined intended use
Use by
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
Note
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The S Spinal System – in sterile condition is addressed in general in the operating instructions for the
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S Spinal System – Lumbar/Deformity TA011187. This information on the sterile-packaged S
the respective information in the instructions for use of the S
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The S Spinal System implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar
and thoracic spine.
The parallel (closed and open) and axial rod connectors are connected to S
a rod parallel or in a line with another rod.
The lateral offset connectors are connected to the S
connectors thus extend the rod to the adjacent spinal column segments.
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The S Spinal System – sterile-packaged comprises:
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Rod connector – parallel (closed and open), axial and lateral offset connectors
Note
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Special S instruments must be used for implanting these components, as well as for the distraction, compression and
reduction of the lumbar and thoracic spine.
Materials
The materials used in the implant are listed on the packaging:
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ISOTAN® titanium forged alloy Ti6Al4V acc. to ISO 5832-3
F
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 acute disorders of the spine that cannot be treated by other therapies::
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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
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Osteoporosis (with the simultaneous use of bone cement and fenestrated screws)
Risk of screw breakage caused by pedicle screws used for spondylolisthesis!
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Support the stabilization measure with interbody fusion (ALIF, PLIF or TLIF).
WARNING
Absolute contraindications
Do not use in the presence of:
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Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant
components; for example, osteopenia, severe osteoporosis, Paget's disease, bone tumors etc.
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Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant
system
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Suspected allergy or sensitivity to the implant materials
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Acute or chronic vertebral infections of a local or systemic nature
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Poor patient compliance or limited ability to follow medical instructions, particularly in the post-op phase,
including with regard to the restrictions on range of movement in terms of physical exercise and occupational
activity
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Cases not listed under indications
Relative contraindications
In the following circumstances, use of the implant system could represent an increased clinical risk and therefore
requires precise, individual assessment by the surgeon:
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Medical or surgical conditions that could negatively impact the success of the implantation, including wound
healing disorders
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Conditions that could subject the spine and implants to excessive pressure; for example,
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pregnancy, obesity, neuromuscular diseases or disorders
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Generally poor condition of the patient; for example, drug or alcohol addiction
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implants supplements
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Spinal System – Lumbar/Deformity.
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Spinal System rods in order to connect
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Spinal System rods in order to place a screw offset. The rod
Side effects and interactions
The general risks of surgery are assumed known and are therefore not described in these instructions for use. Poten-
tial risks and clinical consequences associated with use of the implant system include, but are not limited to:
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Implant failure resulting from excessive load
– Bending
– Loosening
– Breakage
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Poor stabilization, requiring subsequent revision surgery or surgery to remove the implant system
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Failed or delayed fusion
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Infection
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Vertebral fractures
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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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Neurological disorders, including impairment of the gastrointestinal, urological and/or reproductive system
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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 with the implant
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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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Paresis
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Subsequent surgery to remove the implant system
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Metal/foreign body allergy or hypersensitivity
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Dural tears
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Meningitis
Safety notes
CAUTION
According to US federal law, this device may only be sold by or on the otders of a doctor!
The implant has not been evaluated for safety and compatibility in the MR envi-
ronment. It has not been tested for heating, migration or image artifact in the MR
environment. Scanning a patient who has this implant may result in patient injury.
WARNING
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It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly.
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General risk factors associated with surgical procedures are not described in this documentation.
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The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the
established operating techniques.
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The operating surgeon must be thoroughly familiar with the bone anatomy, including the pathways of nerves,
blood vessels, muscles and tendons.
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It is the operating surgeon's responsibility to ensure the correct combination of implant components and their
implantation.
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Aesculap is not responsible for any complications arising from, 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.
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The implant components have been tested and approved in combination with Aesculap components. If other
combinations are used, the responsibility for such action lies with the operating surgeon.
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Do not, under any circumstances, combine implant components from different manufacturers.
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Do not, under any circumstances, use damaged or surgically removed components.
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Implants already used must not be used again.
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Only combine Aesculap modular implant components with each other.
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Delayed healing can cause implant breakage due to metal fatigue.
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The surgeon in charge of the therapy shall make any decision with regard to the removal of implant components
that have been used.
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Damage to the weight-bearing implant and/or bone structures can cause loosening of the components, fracture
of the bone or implant, dislocation and migration and other grave complications.
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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.
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Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
Sterility
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The implant components come individually packed in protective packaging that is labeled according to its con-
tents.
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The implant components have been sterilized by irradiation.
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Store implant components in their original packaging. Remove them from their original protective packaging
only just prior to application.
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Prior to use, check the product expiry date and verify the integrity of the sterile packaging.
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Do not use implant components that are past their expiration date or whose packaging is damaged
Damage to implants caused by processing and resterilization!
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Do not reprocess or resterilize the implants.
WARNING
Applications
The operating surgeon shall devise an operation plan that specifies and precisely documents the following:
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Selection of the implant components by type and size
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Positioning of the implant components in the bone
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Definition of the intraoperative orientation points
The following conditions must be fulfilled prior to application:
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All requisite implant components are ready to hand
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Highly aseptic operating conditions (not contaminated)
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All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems
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The surgeon and the operating team are thoroughly conversant with the surgical technique and the available
range of implants and instruments; appropriate information materials are complete and ready to hand.
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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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The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.