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®
Aesculap
XP
PLASMAPORE
® Cages: CeSPACE®
Intended use
XP
PLASMAPORE
® Cages are used as follows:
■
XP
CeSPACE®
: stabilization of the cervical spine C2-T1 through anterior approach, monosegmental and multiseg-
mental
■
XP
PROSPACE®
: stabilization of the lumbar and thoracic spine through posterior approach, monosegmental and
multisegmental
■
XP
TSPACE®
: stabilization of the lumbar and thoracic spine through transforaminal approach, monosegmental and
multisegmental
Indications
■
Degenerative instability
■
Spondylolisthesis
■
Post-discectomy syndrome
■
Post-traumatic instabilities
Surgically installed implants serve to support normal healing processes. They should neither replace normal struc-
tures of the body nor permanently bear the loads occurring in the case of incomplete healing.
Absolute contraindications
Do not use in the presence of:
■
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.
■
Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant
system
■
Suspected allergy or sensitivity to the implant materials
■
Acute or chronic vertebral infections of a local or systemic nature
■
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:
■
Medical or surgical conditions that could negatively impact the success of the implantation, including wound
healing disorders
■
Conditions that could subject the spine and implants to excessive pressure; for example, pregnancy, obesity, neu-
romuscular diseases or disorders
■
Generally poor condition of the patient; for example, drug or alcohol addition
■
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
Side effects and interactions
In addition to surgery-related risks, potential complications in connection with intervertebral procedures can
include, but are not limited to:
■
Malpositioning, fracture, loosening, migration/dislocation of the implant
■
Spondylolisthesis, pseudarthrosis, inadequate integration of the implant
■
Loss of intervertebral disk height due to removal of healthy bone material
■
Changes in bone density, degenerative changes in the region of the adjacent vertebral bodies
■
Foreign body reactions, allergy
■
Infection
■
Neurological complications caused by overdistraction or trauma of the nerve roots or dura
■
Persistent pain
Materials
The materials used in the implant are listed on the packaging:
■
PEEK-OPTIMA®
■
XP
PLASMAPORE
® surface coating pure titanium acc. to ISO 5832-2/ASTM F1580
■
Titanium alloy Ti6Al4V according to ISO 5832-3 for the X-ray markers (CeSPACE®
■
Tantal according to ASTM F560 for the X-ray markers (PROSPACE®
PEEK-OPTIMA® is a registered trademark of Invibio, Ltd Lancashire FY5 4QD / UK.
Implantation of the PLASMAPORE
The success of the implantation may be jeopardized if the implant bed is not ade-
quately prepared beforehand!
►
Make certain that the endplates of the neighboring vertebral bodies are not
weakened, in order to minimize the risk of migration.
WARNING
►
Make certain that the implant bed is properly prepared to avoid damage to the
implant when it is driven in.
Damage to the implant due to excessive application of force!
►
Always check the correct size every time by using trial implants.
►
Apply the implant in the correct direction. Observe the labeling on the instru-
ment and on the axis of the connector.
WARNING
►
Mount the implant on the insertion instrument hand-tight as far as it will go.
►
When inserting the implant into the intervertebral space, avoid canting and
levering, and take care to maintain an alignment parallel to the endplates.
►
Do not use force during mounting and implantation.
XP
CeSPACE®
Note
For additional stabilization, a cervical plate may be necessary.
XP
PROSPACE®
►
Always implant two implants per layer (PLIF technique).
►
XP
Always use PROSPACE®
in conjunction with an internal fixator.
XP
TSPACE®
►
XP
Always use TSPACE®
in conjunction with an internal fixator.
XP
XP
XP
, PROSPACE®
, TSPACE®
XP
)
XP
XP
, TSPACE®
)
XP
® Cages
General information
The operating surgeon shall devise an operation plan that specifies and accurately 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 are ready to hand.
■
All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
■
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 manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
■
Aseptic operating conditions
■
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.
The patient has been informed of the procedure, taking into account the information provided in the sections on
indications, contraindications, side effects and interactions, and has documented his/her understanding and consent
regarding the following points:
■
In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads.
■
The life-span of the implant depends on the patient's body weight.
■
The implant components must not be overloaded by extreme strains, hard physical labor or sports.
■
Corrective surgery may be necessitated by implant loosening, fracture or loss of correction.
■
Smokers present an increased risk of bone fusion failure.
■
The patient must undergo regular medical follow-up examinations of the implant components.
Safety notes
Damage to the PLASMAPORE
devices!
►
Avoid using high frequency surgical devices in proximity to the implant.
►
If the implant is damaged: Remove the implant.
CAUTION
■
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 ves-
sels, muscles, and tendons.
■
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.
■
The user instructions for individual Aesculap implant components must be followed.
■
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.
■
Do not, under any circumstances, use damaged or surgically excised components.
■
Implants that have been used before must not be reused.
■
The attending physician shall make any decision with regard to the removal of implant components that have
been used,
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
■
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.
Damage to implants caused by processing and resterilization!
►
Do not reprocess or resterilize the implants.
WARNING
Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the relevant
B. Braun/Aesculap office.
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging.
TA-Nr. 013625
2018-07
V6
Änd.-Nr. 58594
XP
® Cages through the use of high frequency surgical
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