Johnson & Johnson DePuy Spine EXPEDIUM SFX, Manual

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B. The patient’s occupation or activity. If the patient is
involved in an occupation or activity that includes
heavy lifting, muscle strain, twisting, repetitive
bending, stooping, running, substantial walking, or
manual labor, he/she should not return to these
activities until the bone is fully healed. Even with full
healing, the patient may not be able to return to
these activities successfully.
C. A condition of senility, mental illness, alcoholism,
or drug abuse. These conditions, among others, may
cause the patient to ignore certain necessary limita­
tions and precautions in the use of the appliance,
leading to implant failure or other complications.
D. Certain degenerative diseases. In some cases,
the progression of degenerative disease may be
so advanced at the time of implantation that it may
substantially decrease the expected useful life of
the appliance. For such cases, orthopedic devices
can only be considered a delaying technique or
temporary remedy.
E.
Foreign body sensitivity.
The surgeon is advised
that no preoperative test can completely exclude the
possibility of sensitivity or allergic reaction. Patients
can develop sensitivity or allergy after implants have
been in the body for a period of time.
F. Smoking. Patients who smoke have been observed to
experience higher rates of pseudarthrosis following
surgical procedures where bone graft is used.
Additionally, smoking has been shown to cause diffuse
degeneration of intervertebral discs. Progressive
degeneration of adjacent segments caused by smok­
ing can lead to late clinical failure (recurring pain) even
after successful fusion and initial clinical improvement.
PRECAUTIONS
1. SURGICAL IMPLANTS MUST NEVER BE REUSED.
An explanted metal implant should never be reimplanted.
Even though the device appears undamaged, it may have
small defects and internal stress patterns that may lead to
early breakage. EXPEDIUM SFX Cross Connectors must
not be reused once they have been final­tightened; use
a new connector if repositioning is necessary.
2. CORRECT HANDLING OF THE IMPLANT IS
EXTREMELY IMPORTANT. Contouring of metal implants
should only be done with proper equipment. The operat­
ing surgeon should avoid any notching, scratching or
reverse bending of the devices when contouring. Altera­
tions will produce defects in surface finish and internal
stresses which may become the focal point for eventual
breakage of the implant. Bending of screws will signifi­
cantly decrease the fatigue life and may cause failure.
3. CONSIDERATIONS FOR REMOVAL OF THE IMPLANT
AFTER HEALING. If the device is not removed after the
completion of its intended use, any of the following
complications may occur: (1) Corrosion, with localized
tissue reaction or pain; (2) Migration of implant position
resulting in injury; (3) Risk of additional injury from post­
operative trauma; (4) Bending, loosen ing, and/or
breakage, which could make removal impractical or diffi­
cult; (5) Pain, discomfort, or abnormal sensations due to
the presence of the device; (6) Possible increased risk
of infection; and (7) Bone loss due to stress shielding.
The surgeon should carefully weigh the risks versus
benefits when deciding whether to remove the implant.
Implant removal should be followed by adequate post­
operative management to avoid refracture. If the patient
is older and has a low activity level, the surgeon may
choose not to remove the implant thus eliminating the
risks involved with a second surgery.
4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative
care and the patient’s ability and willingness to follow
instructions are among the most important aspects of
successful bone healing. The patient must be made
aware of the limitations of the implant, and instructed to
limit and restrict physical activities, especially lifting and
twisting motions and any type of sports participation.
The patient should understand that a metallic implant is
not as strong as normal healthy bone and could loosen,
bend and/or break if excessive demands are placed on
it, especially in the absence of complete bone healing.
Implants displaced or damaged by improper activities
may migrate and damage the nerves or blood vessels.
An active, debilitated, or demented patient who cannot
properly use weight­supporting devices may be
particularly at risk during postoperative rehabilitation.
POSSIBLE ADVERSE EFFECTS
1. Bending or fracture of implant.
2. Loosening of the implant.
3. Metal sensitivity, or allergic reaction to a foreign body.
4. Infection, early or late.
5. Nonunion, delayed union.
6. Decrease in bone density due to stress shielding.
7. Pain, discomfort, or abnormal sensations due to the
presence of the device.
8. Nerve damage due to surgical trauma or presence of
the device. Neurological difficulties including bowel
and/or bladder dysfunction, impotence, retrograde
ejaculation, and paraesthesia.
9. Bursitis.
10. Paralysis.
11. Dural tears experienced during surgery could result in
the need for further surgery for dural repair, a chronic
CSF leak or fistula, and possible meningitis.
12. Death.