B. Braun Aesculap Spine MACS II Gebrauchsanweisung/Technische Beschreibung Seite 2

®
Aesculap
MACS II Anterior Stabilization System
Intended use
The MACS II implants are used for ventral monosegmental and multisegmental stabilization of the lumbar and tho-
racic spine. They comprise:
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Anchoring screws for the vertebral bodies
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Tensioning elements
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Locknuts
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Pre-assembled retaining bolt SX804T
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Connecting plates and, if required, connecting rods of the Aesculap Spine System Evolution, diameter 5.2 mm,
as connection elements
A special instrument set is required to implant these elements.
Materials
The materials used in the implant are listed on the packaging:
■
ISOTAN® titanium forged alloy Ti6Al4V acc. to ISO5832-3
F
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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.
MACS TL® and ISOTAN® are registered trademarks of Aesculap AG, 78532 Tuttlingen / Germany.
System configurations
System incompatibility may result in increased operating time or abortion of the
procedure!
►
Follow only these instructions for use when using the pre-assembled retaining
bolt SX804T.
CAUTION
►
Do not use MACS II in conjunction with the HMA monoaxial or polyaxial
screws of MACS TL®.
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Polyaxial Twin Screw system TL with plate or 2 rods, see Fig. 1.
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Polyaxial Twin Screw system T with plate or 2 rods, see Fig. 2.
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Polyaxial Twin Screw system XL with plate or 2 rods, see Fig. 3.
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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Spinal tumor
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Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis)
■
Post-trauma instability
Risk of screw breakage if anchoring screws are used on the vertebral bodies when
performing a partial or total corporectomy!
►
Support stabilization with intercorporeal fusion (vertebral implant or bone
graft).
CAUTION
Cautionary Notes
This system is not licensed to be screwed onto, or fastened to, the posterior elements (pedicles) of the cervical, tho-
racic or lumbar spine.
Do not use if the patient has:
■
Fever
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Acute or chronic vertebral infections of a local or systemic nature
■
Pregnancy
■
Severe osteoporosis or osteopenia
■
Medical or surgical conditions that could negatively affect the outcome of the implantation
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Severe damaged bone structures that could prevent stable implantation of implant components
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Bone tumors in the region of implant fixation
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Wound healing disorders
■
Inadequate patient compliance
■
Foreign body sensitivity to the implant materials
■
Cases not listed under indications
Side effects and interactions
The application or improper use of this system may result in:
■
Implant failure resulting from excessive load
– Warping or bending
– Loosening
– Breakage
■
Inadequate fixation
■
Failed or delayed fusion
■
Infection
■
Fractured vertebral body or bodies
■
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
■
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
Safety notes
The MACS II Anterior Stabilization System is not licensed to be screwed onto, or fastened to, the posterior elements
(pedicles) of the cervical, thoracic, or lumbar spine.
Note
To prevent corrosion, do not use the MACS II Anterior Stabilization System in conjunction with other materials.
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
■
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.
■
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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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 lack of 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 removed components.
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Implants already used must not be reused.
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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.
■
Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migra-
tion, and other severe 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
Pre-assembled retaining bolt SX804T:
■
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
Damage to implants caused by processing and resterilization!
►
Do not reprocess or resterilize the implants.
WARNING
Anchoring screws for the vertebral bodies, tensioning elements, locknuts, as well as connecting plates and rods:
■
The implant components are supplied in unsterile condition.
■
The implant components are packaged individually.
►
Store the implant components in their original packaging and only remove them from their original and protec-
tive packaging immediately prior to application.
►
Use the implant system storage devices for processing, sterilization and sterile setup.
►
Ensure that the implant components do not come into contact with each other or with instruments in their
implant system storage devices.
►
Ensure that the implant components are not damaged in any way.
Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the fol-
lowing validated reprocessing procedure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for reprocessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
It should be noted that successful reprocessing of this medical device can only be guaranteed following prior valida-
tion of the reprocessing method. The operator/reprocessing technician is responsible for this.
The recommended chemistry was used for validation.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
www.aesculap-extra.net.
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
Validated reprocessing procedure
Cleaning/disinfection
Validated cleaning and disinfection procedure
Validated procedure Specific requirements
■
Manual cleaning with ultrasound
Do not use brushes or other
and immersion disinfection
abrasives that would damage
the product surfaces and could
cause corrosion
■
To prevent internal stresses on,
and weakening of the implants:
avoid scoring or scratching of
the implant components
■
Drying phase: Use a lint-free
cloth or medical compressed air
Reference
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
ultrasound and immersion dis-
infection