Universal Clamp—Surgical Technique Guide
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•
Additional fixation is required at the cephalad and caudal
ends of the construct in scoliosis surgery, especially in
case of obesity, extreme kyphosis or muscular weakness,
except where additional fixation would increase the risk
to the patient.
•
If any implant or instrument comes in contact
with a non-sterile surface it should not be used.
Postoperative
•
Adequately instruct the patient. Postoperative care and
the patient’s ability and willingness to follow instructions
are one of the most important aspects of successful
bone healing. The patient must be made aware of the
limitations of the implant and that physical activity and
full weight bearing have been implicated in fracture.
The patient should understand that an implant is
not as strong as normal, healthy bone and will
fracture if excessive demands are placed on it in
the absence of complete bone healing. An active,
debilitated, or demented patient who cannot properly
use weight-supporting devices may be particularly
at risk during postoperative rehabilitation.
Adverse Effects
Complications and adverse reactions have been reported
with the use of similar spinal instrumentation systems.
These adverse effects, including the possibility of death,
should be discussed with the patient prior to surgery.
Additional surgery may be required to correct any of these
potential adverse effects.
1.
Non-union, delayed union.
2.
Disassembly, fraying, kinking, loosening, bending
or breakage of any or all of the Universal Clamp System
implant components.
3.
Metal sensitivity, polyester sensitivity or allergic reaction
to a foreign body.
4.
Infection.
5.
Foreign body reaction to the implants including possible
tumor formation.
6.
Pain, discomfort, or abnormal sensations due to the
presence of the device.
7.
Pressure on the skin from component parts, where there
is inadequate tissue coverage over the implant causing
skin irritation.
8.
Loss of proper spinal curvature, correction height
and/or reduction.
9.
Implants cutting through soft osteoporotic, osteopenic
or cancellous bone.
10.
Bone forming around the implant making removal
difficult or impossible.
11.
Cessation of growth in the operated portion of bone.
12.
Decrease in bone density due to stress shielding.
13.
Vascular and/or nerve damage due to surgical trauma
or presence of the device. Neurological difficulties
including bowel and/or bladder dysfunction, impotence,
retrograde ejaculation, and paraesthesia.
14.
Bursitis.
15.
Dural leak.
16.
Paralysis.
17.
Death.
18.
Erosion of blood vessels due to the proximity of the device,
leading to hemorrhage and/or death.
Magnetic Resonance Imaging (MRI)
Safety and Compatibility
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 environment.
In the event of exposure to foreseeable environmental
conditions such as magnetic fields the user and/or patient
should be informed of the following:
Precautions
•
This device has not been evaluated for safety and
compatibility in the MR environment.
•
This device has not been tested for heating or migration
in the MR environment.
•
There is a potential for heating and migration in the
MR environment.
•
There is the potential for metal implants to create MR
imaging artifacts in the vicinity of the implant.
