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vertebral body resected or excised for the treatment of
tumors, to achieve anterior decompression of the spinal
cord and neural tissues, and to restore the height of a
collapsed vertebral body.
The VBR Spinal Systems are also indicated for treating
fractures of the thoracic and lumbar spine.
The VBR Spinal Systems are designed to restore the
biomechanical integrity of the anterior, middle and posterior
spinal column even in the absence of fusion for a prolonged
period.
The VBR Spinal Systems are intended for use with DePuy
Spine supplemental internal fixation.
CONTRAINDICATIONS
1. Use of these systems is contraindicated when there is
active systemic infection, infection localized to the site of
the proposed implantation, or when the patient has
demonstrated allergy or foreign body sensitivity to any of
the implant materials.
2. Severe osteoporosis may prevent adequate fixation and
thus preclude the use of this or any other orthopaedic
implant.
3. Conditions that may place excessive stresses on bone
and implants, such as severe obesity or degenerative
diseases, are relative contraindications. The decision
whether to use these devices in such conditions must be
made by the physician taking into account the risks
versus the benefits to the patient.
Use of these implants is relatively contraindicated in patients
whose activity, mental capacity, mental illness, alcoholism,
drug abuse, occupation, or lifestyle may interfere with their
ability to follow postoperative restric tions and who may
place undue stresses on the implant during bony healing
and may be at a higher risk of implant failure.
WARNINGS, PRECAUTIONS AND
ADVERSE EFFECTS CONCERNING
SPINAL FIXATION IMPLANTS
Following are specific warnings, precautions and adverse
effects that should be understood by the surgeon and
explained to the patient. These warnings do not include all
adverse effects that can occur with surgery in general, but are
important considerations particular to devices such as the
VBR Spinal System. General surgical risks should be
explained to the patient prior to surgery.
The VBR Spinal System implants are intended to support
the anterior, middle, and posterior vertebral column while
fusion is taking place. These implants are intended to be
permanent. The following recommenda tions for removal of
hardware apply to the supplemental internal fixation
implants used in this procedure.
WARNINGS
1.
CORRECT SELECTION OF THE IMPLANT IS
EXTREMELY IMPORTANT. The potential for satis factory
anterior column support is increased by the selection of
the proper size device. While proper selection can help
minimize risks, the size and shape of human bones
present limitations on the size, shape and strength of
implants. Internal fixation devices cannot withstand activ-
ity levels equal to those placed on normal healthy bone.
No implant can be expected to withstand indefinitely the
unsupported stress of full weight bearing.
2.
IMPLANTS CAN BREAK WHEN SUBJECTED TO THE
INCREASED LOADING ASSOCIATED WITH DELAYED
UNION OR NONUNION. Internal fixation appliances are
load-sharing devices that are used to obtain an alignment
until normal healing occurs. If healing is delayed, or does
not occur, the implant may eventually break due to
material fatigue. The degree or success of union, loads
produced by weight bearing, and activity levels will,
among other conditions, dictate the longevity of the
implant. Notches, scratches or bending of the implant
during the course of surgery may also contribute to early
failure. Patients should be fully informed of the risks of
implant failure.
3.
MIXING METALS CAN CAUSE CORROSION. There are
many forms of corrosion damage and several of these
occur on metals surgically implanted in humans. General
or uniform corrosion is present on all implanted metals
and alloys. The rate of corrosive attack on metal implant
devices is usually very low due to the presence of
passive surface films. Dissimilar metals in contact, such
as titanium and stainless steel, accelerate the corrosion
process of stainless steel and more rapid attack occurs.
The presence of corrosion often accelerates fatigue
fracture of implants. The amount of metal compounds
released into the body system will also increase. Internal
fixation devices, such as rods, hooks, wires, etc., which
come into contact with other metal objects, must be made
from like or compatible metals. Avoid coupling of
stainless steel with the VBR Spinal System implants.
PRECAUTIONS
1.
SURGICAL IMPLANTS MUST NEVER BE REUSED. An
explanted implant should never be reimplanted. Even
though a device appears undamaged, it may have small
defects and internal stress patterns that may lead to early
breakage. Reuse can compromise device performance
and patient safety. Reuse of single use devices can also
cause cross-contamination leading to patient infection.
