Avenue
®
T TLIF Cage—Surgical Technique Guide
23
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Any decision by a surgeon to remove the device should
take into consideration such factors as the risk to the
patient of the additional surgical procedure as well as the
difficulty of removal.
•
Implant removal should be followed by adequate
postoperative management to avoid fracture.
•
Before implanting the Avenue T TLIF Cage, the vertebral
plates must be carefully prepared, being careful not to
weaken the cortical bone to avoid implant subsidence.
•
The setting and possible repositioning of the Avenue T
TLIF Cage must be done with the cage holder attached
to the cage.
•
Do not attempt to reposition the implant after anchoring
plates have been deployed into the vertebral endplates.
•
As the Avenue T implants must be used with supplemental
fixation, close attention should be paid during the insertion
of the anchoring plates, in order to limit risk of contact
between the anchoring plates and additional spinal
hardware (e.g., pedicle screws).
•
The Avenue T TLIF Cage system has not been evaluated for
safety and compatibility in the MR environment.
•
The Avenue T TLIF Cage system has not been evaluated for
heating or migration in the MR environment.
Precautions
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Being a technically demanding procedure presenting a
risk of serious injury to the patient, the implantation of
intervertebral body fusion systems should be performed
only by experienced spine surgeons with specific training
in the use of this system and who have knowledge of the
present instructions for use.
•
Based on fatigue testing results, when using the Avenue T
TLIF Cage system, the physician/surgeon should consider
the levels of implantation, patient weight, patient activity
level, other patient conditions, etc., which may impact on
the performance of this system.
•
Patients who smoke have been shown to have an increased
incidence of non-unions. Such patients should be advised
of this fact and warned of the potential consequences.
•
If the patient is involved in an occupation or activity which
applies inordinate stress upon the implant (e.g., running,
lifting of significant loads, or muscle strain), resultant forces
can cause failure of the device.
•
In some cases, progression of degenerative disease
may be so advanced at the time of implantation that
they substantially decrease the expected useful life to
the implant. In such cases, orthopedic devices may be
considered only as a delaying technique or to provide
temporary relief.
•
Before clinical use, the surgeon should thoroughly
understand all aspects of the surgical procedure and
limitations of the system. This device is recommended
for use only by surgeons familiar with preoperative and
surgical techniques, cautions and potential risks associated
with spinal surgery. Knowledge of surgical techniques,
proper reduction, selection and placement of implants,
and pre- and post-operative patient management are
considerations essential to a successful surgical outcome.
–
Instructions for patient care following treatment should
be provided by the surgeon or another
medical professional.
•
Patients should be instructed in detail about the limitations
of the implants, including but not limited to the impact of
excessive loading through patient weight or activity, and
should be taught to govern their activities accordingly.
Avenue T implants (cages and anchoring plates) are load-
sharing devices which hold a vertebra in alignment until
healing occurs. If healing is delayed or does not occur, the
implant could eventually break due to material fatigue.
•
Risks associated with general surgery by transforaminal
approach, orthopedic surgery, and the use of general
anesthesia should be explained to the patient prior
to surgery.
•
Appropriate selection, placement and fixation of the
spinal system components are critical factors which
affect implant service life. Accordingly, strict adherence
to the indications, contraindications, precautions, and
warnings for this product is essential to potentially
maximize service life.
•
Care must be taken to protect the components from being
marred, nicked or notched as a result of contact with metal
or abrasive objects. Alterations will produce defects in
surface finish and internal stresses which may become the
focal point for eventual breakage of the implant.
•
After any surgery, it is necessary to check the proper
position of the implants and to follow the evolution of the
fusion using appropriate techniques.
•
For the anchoring plates, it is imperative to respect the
following points:
–
During multi-level implantations, care should be taken
during plate selection to minimize the possibility of
interference with the adjacent plate.
–
Ensure the cage does not protrude proximally outside the
intervertebral disc space to be sure that the anchoring
plates are properly positioned in the vertebral body.
–
If VerteBRIDGE is used in conjunction with pedicle
screws, use fluoroscopy to verify the trajectory of
the anchoring plates to avoid impingement with
pedicle screws.
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Sale of this product is restricted to physicians.
