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Avenue
®
T TLIF Cage—Surgical Technique Guide
IMPORTANT INFORMATION ON THE AVENUE T IMPLANT DEVICE
Device Description
The Avenue T implants are devices whose primary functions
are to add a solid structure to a graft so as to enable the
stabilization of intervertebral height, after discectomy, during
the time of graft setting and achieve a maximum surface of
fusion. Various sizes of these implants are available, so that
adaptations can be made to take into account the pathology
and individual patient anatomy. In addition, so as to favor
bone growth, the Avenue T TLIF Cage must be filled with
bone graft.
Indications for Use
The Avenue T TLIF Cage System is indicated for intervertebral
body fusion of the lumbar spine, from L2 to S1, in skeletally
mature patients who have had six months of non-operative
treatment. The device is intended for use at either one level
or two contiguous levels for the treatment of degenerative
disc disease (DDD) with up to Grade I spondylolisthesis or
retrolisthesis. DDD is defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and
radiographic studies. The Avenue T TLIF Cage is designed
for use with or without integrated fixation and must be used
in conjunction with supplemental fixation cleared by FDA
for use in the lumbar spine. The device is implanted via a
transforaminal approach and intended for use with autograft
and/or allogenic bone graft composed of cancellous and/or
corticocancellous bone graft to facilitate fusion.
Contraindications
Contraindications include, but are not limited to:
•
Patients under treatment inhibiting bone fusion.
•
Cardiac problems.
•
Abuse of medicine, drugs, tobacco or alcohol (which
change the ossification power).
•
Material sensitivity, documented or suspected.
•
Any mental or neuromuscular disorder which would create
an unacceptable risk of fixation failure or complications in
post-operative care.
•
Bony abnormalities or bone stock compromised by disease
(such as osteopenia, osteoporosis), infection or prior
implantation preventing safe support and/or fixation to the
implant.
•
Morbid obesity can produce loads on the spinal system
which can lead to failure of the fixation of the device or to
failure of the device itself.
•
Recent infection, fever or hyper-leukocytosis.
•
Open wounds.
•
Patients having inadequate tissue coverage over the
operative site.
•
Pregnancy.
•
Inflammation.
•
Other medical (for example : anesthetics risks) or
surgical conditions which would preclude the potential
benefit of spinal implant surgery such as the presence
of bone tumors, congenital abnormalities, elevation of
sedimentation rate unexplained by other diseases.
Warnings
•
Potential risks associated with the use of this system,
which may require additional surgery, include device
component fracture, loss of fixation, non-union, fracture
of the vertebra, neurological injury, and vascular or
visceral injury.
•
Implants damaged in any way that can affect their form or
functioning must not be implanted.
•
Under no circumstances may the implants be re-used.
Although the device may appear intact on removal,
internal modification due to the stress and strains
placed on it, or small defects may exist which may
lead to fracture of the implant.
•
Implants removed from a patient that contact bodily
tissues or fluids should never be reused at risk of
contamination of the patient.
•
Devices cannot withstand activity and loads equal to
those placed on normal healthy bone. Until arthrodesis of
segment(s) is confirmed, do not subject this device to the
stress of heavy loads, or implant failure may result.
•
Mixing Metal: Some degree of corrosion occurs on
all implanted metal and alloys. Contact of dissimilar
metals (e.g. stainless steels and titanium), however,
may accelerate this corrosion process. The presence of
corrosion may accelerate fatigue fracture of implants and
the amount of metal compounds released into the body
system may also increase.
•
Manufacturers employ different materials, manufacturing
specifications and differing design parameters.
Components of the Avenue T TLIF Cage system should
not be used in conjunction with components from any
other manufacturer.
•
The device can break if it is subjected to increased loading
associated with delayed union or non-union. If healing is
delayed or does not occur, the implant could eventually
break due to material fatigue. Factors such as the patient
weight, activity level, and compliance to weight bearing or
load bearing instructions, have an effect in the stresses to
which the implant may be subjected, and may affect the
longevity of the implant.
