Publicité
Les langues disponibles
Les langues disponibles
Caspar Plates and Screws for
Anterior Cervical Fusion
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Intended use
CASPARevolution-implants are used for anterior mono- and multisegmental
stabilization of the cervical spine until bone fusion is established.
The implants are available in various shapes and sizes to adapt them to the
individual patient and pathology.
CASPARevolution implants include:
• Bone plates
– of different length from 24 to 90 mm
– factory pre-bent, longitudinally and vertically
– adapting to the anatomic shape of the cervical spine
• Monocortical screws
– 4.0 mm diameter
• Bicortical screws
– 3.5 mm diameter
– 4.5 mm diameter (for case in which the 3.5-mm screw would shear
out)
Caspar stainless steel screws are used with Caspar stainless steel plates.
Caspar screws of titanium alloy are used with Caspar titanium plates.
Materials
Materials
ISOTAN®
titanium forged alloy Ti6Al4V conforming
F
to ISO 5832-3
ISOTAN®
pure titanium conforming to ISO 5832-2
P
The screws made of titanium forged alloy and the bone plates made of pure
titanium are used together.
The titanium implants are coated with a colored oxide. Slight color changes
can occur, but will not have any bearing on the quality of the implant.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen /
Germany.
Indications
Surgically inserted implants serve to support normal healing processes. They
are not intended to replace normal body structures or as permanent support
for loads occurring in cases of failed or delayed healing.
Use for mono- and multisegmental fusions in cases of cervical spine instabil-
ities caused by:
• Tumors
• Degenerative diseases of intervertebral discs
• Degenerative disc disease is instability and one or more of the following:
decreased disc height, bridging of the vertebral endplates, osteophyte
formation and/or scarring or thickening of the ligamentous tissue.
• Fractures
Contraindications
Do not use in the presence of:
• Acute and chronic infections in the region of the implant fixation or the
spine; systemic infections
• Severe defects of the bone structures of the affected vertebral bodies,
which need to be intact for a stable implantation to be possible
• Bone tumors in the region of the implant anchoring
• Anticipated overload on the implant
• Metal or foreign body sensitivity to the implant materials
• Profound osteopenia, osteoporosis, or other bone loss
• Pregnancy
• Generally poor condition
• Medical or surgical conditions that could preclude the success of the
implantation
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Psychosocial problems
• Lack of patient's cooperation
Side-effects and adverse interactions
ACF plating involves the following potential risks:
• Neurological deficits, hemorrhages and infections
• Loss of intervertebral disc height due to subsidence or resorption of bone
material, or to the removal of healthy bone material
Complications that can generally occur in connection with vertebral surgery:
• Pseudarthrosis
• Infections
• Spondylolisthesis
• Incorrect implant position
• Bone fragment resorption
• Delayed or failed union can lead to implant breakage due to material
fatigue.
The life span of the implant is affected by the following factors:
• Body weight of the patient
• Degree of physical activity
• Compliance with instructions with regard to carrying loads
The side effects and interactions listed above do not include every unwel-
come effect that can generally occur in the context of surgical interventions.
Rather, they are important factors to be considered when using internal fix-
ation devices made of metal.
Safety notes
• The implant components were tested and approved for use in combina-
tion with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
• General risk factors associated with surgical procedures are not described
in this documentation.
• It is the operating surgeon's responsibility to ensure that the surgical pro-
cedure is performed properly.
• The operating surgeon must have a thorough command of all hands-on
and conceptual aspects of the established operating techniques.
• The operating surgeon must be thoroughly familiar with bone anatomy,
including the pathways of nerves, blood vessels, muscles and tendons.
• Aesculap is not responsible for any complications arising from incorrect
establishment of indication, choice of incorrect implant, improperly com-
bined implant components and/or operating techniques, limitations of
the therapeutic method, or inadequate asepsis.
• The instructions for use of the individual Aesculap implant components
must be observed.
• Always observe the instructions for use of the instruments of the CASPAR
ACF system (TA008349 and TA009343).
• Only combine Aesculap modular implant components with each other.
• Titanium implants may not be combined with steel implants.
• Do not use damaged or surgically excised components under any circum-
stances.
• Implants that have already been 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 keeps the patient well
informed.
This device is not approved for screw attachment or fixation to the posterior
elements (pedicles) of the cervical, thoracic or lumbar spine
Sterility
The implants have to be sterilized before they can be used:
Designation
• The implant components are supplied in unsterile condition.
• The implant components are delivered each in an individual packaging.
Screws
For implant components in original packaging:
Store implant components in their original packaging. Remove them
from their original protective packaging only just prior to application.
Bone plates
Use the implant system storage devices for processing, sterilization and
sterile setup.
Make certain that the implant components in their implant system stor-
age devices will not get into contact with each other or with instru-
ments.
Make certain that the implant components will not be damaged under
any circumstances.
For implant components that are to be resterilized:
WARNING
Sterilization method and parameters
Note
Observe all relevant national regulations and standards concerning process-
ing.
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
Up-to-date information on processing can be found on the Aesculap Extranet
at www.aesculap-extra.net
Sterilize with steam, observing the following rules:
Carry out sterilization through a validated steam sterilization process
(e.g. in a sterilizer conforming to EN 285/ANSI/AAMI/ISO 11134-1993,
ANSI/AAMI ST46-1993, and validated acc. to EN 554/ISO 13683). For
the fractionated-vacuum process, sterilization has to be carried out with
the 134 °C/2 bar program, with a holding time of least 4 minutes.
Sterilization for the US market
• Sterilization of the device may be accomplished by steam.
• Aesculap does not recommend the device be sterilized by "Flash" or
chemical sterilization.
• Surgical instruments may also be placed within an Aesculap rigid steril-
ization container (sterile container) for processing under generally
accepted hospital in-use conditions.
The recommended sterilization parameters are as follows:
Sterilization
Temp.
method
Pre-vacuum
270—275 °F
Intraoperative contamination with blood, secre-
tions and other fluids may render the affected
component unsuitable for resterilization!
Handle the implants with new gloves only.
Keep the implant system storage devices
covered or closed.
Put away implant system storage devices
separately from instrument trays.
If implant system storage devices are not
available, reprocess implant components
individually and separately. When doing this,
make certain that the implant components
are not damaged.
Carry out manual and, if necessary, addi-
tional ultrasound pre-cleaning of soiled
implant components.
Carry out the final rinse with distilled, dem-
ineralized or fully desalinated water.
Always observe the applicable hospital
guidelines concerning the supply of sterile
materials.
Minimum exposure time
Wrapped
In a sterile container
system
4 min
4 min
WARNING for the US market
If this device is/was used in a patient with, or suspected of having
Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must
be destroyed due to the inability to reprocess or sterilize to eliminate the
risk of cross-contamination!
Application
Risk to the patient due to inadequate expertise of
the operating surgeon!
Make certain the surgeon possesses detailed
knowledge in spine surgery and about the
biomechanical conditions at the spine.
WARNING
The operating surgeon shall devise an operation plan that specifies and accu-
rately documents the following:
• Selection of the implant components and their dimensions
• Positioning of the implant components in the bone
• 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 special instrument set must be ready for implanting the implant com-
ponents and for the distraction, compression and repositioning of the cer-
vical spine
• 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.
• The operating surgeon must be familiar with the rules governing medical
practice, the current state of scientific knowledge, and the contents of
relevant articles by medical specialists from professional literature.
• The manufacturer has been consulted if the preoperative situation was
unclear and if implants were found in the area operated on.
Note
The surgical procedure for implanting the CASPARevolution implants and
application advisories for the system components are described in detail in the
operating manual. The operating manual can be ordered under article number
O15902 from the address indicated below.
The operative procedure has been explained to the patient, and the latter's
understanding of the following information has been documented:
• In cases of delayed or incomplete fusion, the implants may break or
loosen as a result of excessive strains.
• The life-span of the implant depends on the patient's body weight.
• The implants must not be exposed to overload due to excessive strains,
hard physical work or sports activities.
• If the implant becomes loose, fractures or deviates from its correction
position, a revision operation must be performed.
• The patient must undergo regular check-ups of the implant components,
performed by a physician.
• We recommend informing the patient about alternative methods of
treatment.
Implantation of the CASPARevolution implant requires the following steps:
Select appropriate CASPARevolution implants according to the indica-
tion, preoperative planning and bone situation found intraoperatively.
To avoid internal stresses and weakening of the implant: avoid scoring
or scratching of implant components.
CASPARevolution bone plates
Select bone plates of appropriate length to cover the region to be fix-
ated.
If necessary adjust the curvature of the bone plates to the individual sit-
uation or to the required spine lordosis.
Weakening or breakage of the bone plates due to
excessive bending!
Check that the bone plates are fully intact
prior to application.
For bending the bone plates, only use bend-
WARNING
ing instruments of the CASPARevolution
instrument set.
Bend the bone plates only once at any one
place.
Avoid excessive bending.
Do not bend back bone plates that have
already been bent.
Note
Metal implants other than the bone plates must not be bent.
CASPARevolution screws
Be certain to choose the correct diameter and length when selecting the
CASPARevolution screws to be used.
Apply the implantation instruments in the correct way.
Completely screw in the screws into the bone plates.
Trauma to the spinal cord and nerve roots due to
incorrect application!
Alignment and insertion of the instruments
and screws may only be carried out under
radiographic control or aided by a navigation
WARNING
system.
Distributor in the US/Contact in Canada for
product information and complaints
Aesculap Implant Systems Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
Further information about B. Braun/Aesculap implant systems is available
from B. Braun/Aesculap or the B. Braun/Aesculap office responsible.
TA-Nr.: 009609
11/09
Änd.-Nr.: 29902/32607
Publicité
