Johnson & Johnson DePuy Spine EXPEDIUM SFX, Manual

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use of these spinal systems. The implanting surgeon
should consider carefully the size and type of implants
most suitable for the pediatric patient’s age, size, weight
and skeletal maturity. Since pediatric patients may have
additional growth potential following implant surgery, the
likelihood of a subsequent removal and/or revision surgery
is greater than in adult patients.
POSTOPERATIVE MOBILIZATION
Until X­rays confirm the maturation of the fusion mass,
external immobilization (such as bracing or casting)
is recommended.
Instructions to the patient to reduce stress on the implants
are an equally important part of the attempt to avoid the
occurrence of clinical problems that may accompany
fixation failure.
CONTRAINDICATIONS
Disease conditions that have been shown to be safely and
predictably managed without the use of internal fixation
devices are relative contraindications to the use of
these devices.
Active systemic infection or infection localized to the site
of the proposed implantation are contraindications to
implantation.
Severe osteoporosis is a relative contraindication because
it may prevent adequate fixation of spinal anchors and
thus preclude the use of this or any other spinal
instrumentation system.
Any entity or condition that totally precludes the possibility
of fusion, i.e., cancer, kidney dialysis, or osteopenia is a
relative contraindication. Other relative contraindications
include obesity, certain degenerative diseases, and foreign
body sensitivity. In addition, the patient’s occupation or
activity level or mental capacity may be relative contraindi­
cations to this surgery. Specifically, patients who because
of their occupation or lifestyle, or because of conditions
such as mental illness, alcoholism, or drug abuse, may
place undue stresses on the implant during bony healing
and may be at higher risk for implant failure. See also the
WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE
EFFECTS CONCERNING TEMPORARY METALLIC
INTERNAL FIXATION DEVICES section of this insert.
WARNINGS, PRECAUTIONS, AND
POSSIBLE ADVERSE EFFECTS
CONCERNING TEMPORARY METALLIC
INTERNAL FIXATION DEVICES
Following are specific warnings, precautions, and pos­
sible 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
metallic internal fixation devices. General surgical risks
should be explained to the patient prior to surgery.
WARNINGS
1. CORRECT SELECTION OF THE IMPLANT IS
EXTREMELY IMPORTANT. The potential for satisfac­
tory fixation is increased by the selection of the proper
size, shape, and design of the implant. While proper
selection can help minimize risks, the size and shape of
human bones present limitations on the size, shape and
strength of implants. Metallic internal fixation devices
cannot withstand activity 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
load­sharing devices that are used to obtain alignment
until normal healing occurs. If healing is delayed, or
does not occur, the implant may eventually break due
to metal 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, accelerates 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 com­
pounds released into the body system will also increase.
Internal fixation devices, such as rods, hooks, etc.,
which come into contact with other metal objects, must
be made from like or compatible metals.
4. PATIENT SELECTION. In selecting patients for internal
fixation devices, the following factors can be of extreme
importance to the eventual success of the procedure:
A.
The patient’s weight.
An overweight or obese patient
can produce loads on the device that can lead to
failure of the appliance and the operation.