Following are specific warnings, precautions, and adverse effects,
which should be understood by the surgeon and explained to the
patients. These warnings do not include all adverse effects, which can
occur with surgery in general, but are important considerations
particular to metallic and polyester internal fixation devices.
General surgical risks should be explained to the patient prior to surgery.
- In the U.S.A., this product has labeling limitations.
- Potential risks identified with the use of this device system,
which may require additional surgery, include:
-Device component fracture.
-Loss of fixation.
-Fracture of the vertebra.
-Vascular or visceral
- Implants can break when subjected to the prolonged
loading associated with delayed union or non-union. Internal
fixation appliances are load sharing devices which 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
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. Patients should be fully informed of
the risks of implant failure.
- 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 compounds released into the body system
will also increase. Internal fixation devices, such as rods, hooks,
wires, etc. which come into contact with the UNIVERSAL CLAMP
System, must be made from like or compatible metals.
selecting patients for internal fixation, the following factors can
be of extreme importance to the eventual success of the
a. The patient’s weight. An overweight
or obese patient can produce loads on the device
lead to failure of the appliance and the surgical treatment.
The patient’s occupation or activity. If the patient is involved in an
occupation or activity
that includes substantial walking,
running, lifting or muscle strain, the resultant forces
can cause failure of the device.
c. A condition of senility,
mental illness, alcoholism, or drug abuse. These conditions,
among others, may cause the patient to ignore certain necessary
precautions in the use of the appliance,
leading to implant failure or other complications.
degenerative diseases. In some cases, the progression of degenerative
may be so advanced at the time of implantation
that it may substantially decrease the
life of the appliance. For such cases, orthopaedic devices can only
considered a delaying technique or temporary
e. Foreign body sensitivity. Where material sensitivity
is suspected, appropriate tests should
be made prior to
material selection or implantation.
f. The Universal Clamp
System has not been evaluated for safety and compatibility in the MR
(Magnetic Resonance) environment. The Universal Clamp System has
not been tested for heating or migration in the MR
g. Elevators and band passers should not be used
for sublaminar passage. They should only be used for passage
around the transverse process.