B. Braun Aesculap Spine MACS II Gebrauchsanweisung Seite 2

MACS II Anterior Stabilization System
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Intended use
MACS II implants are designed for ventral, monosegmental, and multisegmental stabilization of the lumbar and
thoracic vertebrae.
They comprise:
• Anchoring screws for the vertebral bodies
• Tensioning elements
• Locknuts
• Pre-assembled SX804T retaining bolts
• 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 ISO 5832-3
F
• ISOTAN® pure titanium acc. to ISO 5832-2
P
The titanium implants are coated with a colored oxide. Slight variations in color may occur, but will not affect the
quality of the implant.
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®.
• Polyaxial Twin Screw system TL with plate or 2 rods, see Fig. 1.
• Polyaxial Twin Screw system T with plate or 2 rods, see Fig. 2.
• Polyaxial Twin Screw system XL with plate or 2 rods, see Fig. 3.
Indications
The purpose of implants performed intraoperatively is 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:
• Fractures
• Spinal tumor
• 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
Contraindications
Do not use 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 affect the outcome of the implantation
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Adiposity
• Mental illness
• Severely damaged bone structures that could prevent stable implantation of implant components
• Bone tumors 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
Application or incorrect application of this system entails the following risks:
• Implant failure resulting from excessive load
– Warping or bending
– Loosening
– Breakage
• Inadequate fixation
• Failed or delayed fusion
• Infection
• Fractured vertebral body or bodies
• Trauma to:
– nerve roots
– spinal cord
– blood vessels
– organs
• Changes of the normal spine lordosis
• Impairment of the gastrointestinal, urological, and/or reproductive systems
• Pain or indisposition
• Decreased bone density due to load avoidance
• Bone atrophy/fracture above or below the spine section provided for
• Limited physical ability
• 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.
• 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.
• 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
vessels, muscles, and tendons.
• 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 erroneous indication, wrong choice of implant,
incorrect combination of implant components and operating technique, the limitations of the treatment method,
or inadequate asepsis.
• The instructions for use of the individual Aesculap implant components must be observed.
• The implant components were tested and approved in combination with Aesculap components. If other
combinations are used, the responsibility for such action lies with the operating surgeon.
• Do not, under any circumstances, combine implant components from different manufacturers.
• Do not, under any circumstances, use damaged or surgically excised components.
• Implants that have been used before must not be reused.
• Delayed healing can cause implant breakage due to metal fatigue.
• Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation,
migration, 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
importance.
• The physician in charge decides whether implanted implant components should be removed.
Sterility
• Pre-assembled retaining bolt SX804T is individually packaged in labeled protective packaging.
• Pre-assembled retaining bolt SX804T is sterilized by irradiation.
Store pre-assembled retaining bolt SX804T in the original packaging; only remove from the original protective
packaging immediately prior to use.
Prior to use, check the product expiry date and verify the integrity of the sterile packaging.
Do not use pre-assembled retaining bolt SX804T if the expiry date has passed or the packaging is damaged.
Damage to the pre-assembled retaining bolt caused by reprocessing and resterilization!
Do not reprocess or resterilize the pre-assembled retaining bolt.
WARNING
• Anchoring screws for the vertebral bodies, tensioning elements, locknuts, connecting plates, and rods are
supplied in a non-sterile condition.
• Anchoring screws for the vertebral bodies, tensioning elements, locknuts, connecting plates, and rods are
individually packaged.
Store implant components in their original packaging and remove from their original protective wrapping only
immediately prior to processing.
Use the implant system storage devices for processing, sterilization, and sterile preparation of the anchoring
screws for the vertebral bodies, tensioning elements, locknuts, connecting plates, and rods.
Ensure that the implant components in their implant system storage devices do not come into contact with each
other or with instruments.
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
following validated processing procedure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of the products.
Note
Successful processing of this medical product can only be ensured if processing is performed through a validated
processing procedure. The operator/sterile processing technician is responsible for this. Due to process tolerances, the
manufacturer's specifications can only serve as an approximate guide for assessing the processing procedures applied
by the individual operator/processors.
Note
Up-to-date information about instrument reprocessing is also available on the Aesculap extranet at www.aesculap-
extra.net.
Validated reprocessing procedure
Manual cleaning with ultrasound and immersion disinfection
Phase Step T
[°C]
RT
I
Ultrasonic cleaning
(cold)
RT
II
1st Intermediate
(cold)
rinse
RT
III
Disinfection
(cold)
RT
IV
2nd Intermediate
rinse
RT
V
Final rinse
(cold)
-
VI
Drying
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
t Conc. Water Chemical
[min] [%] quality
5 2
D–W BBraun Stabimed; phenol
aldehyde-free and QUAT-free
1 -
D–W -
15 2
DM-W BBraun Stabimed; phenol
aldehyde-free and QUAT-free
1 -
FD-W -
0,5 -
FD-W -
- -
- -