Contraindications - Chm Charspine System Bedienungsanleitung

tion on posterior vertebral endplates producing symptomatic nerve
root and/or spinal cord compression confirmed by radiographic studies.
Patients qualified for treatment should be skeletally mature and have
had six months of non-operative treatment.
2. For the implantation of the aforementioned products, ChM's specialist
instrument sets are dedicated. Along with the instrument set, illustrated
surgical technique is also provided. Surgical technique is not a detailed
instruction of conduct. This is the physician that determines the proper
technique and detailed surgical procedure for a particular patient.

2 CONTRAINDICATIONS

1. Contraindications may be relative or absolute. The choice of particular de-
vice must be carefully considered in terms of patient' s overall condition.
Conditions listed below may preclude or reduce the chance of successful
outcome:
1) Infection local to the operative site.
2) Signs of local inflammation.
3) Fever or leukocytosis.
4) Morbid obesity (defined according to the WHO standards).
5) Pregnancy.
6) Neuromuscular disorders which can create unacceptable risk of fixation
failure or complications in postoperative care.
7) Any other condition which would preclude the potential benefit
of implant application and may disturb the normal process of bone
remodeling, e.g. the presence of tumours or congenital abnormalities,
fracture local to the operating site, elevation of sedimentation rate un-
explained by other diseases, elevation of white blood cells (WBC) count,
or a marked left shift in the WBC differential count.
8) Suspected or documented allergy or intolerance to implant materials.
Surgeon shall find out if the patient develops allergic reaction to the ma-
terial of the implant (content of the implant material is presented in IM-
PLANT MATERIAL).
9) Any case not needing a surgical intervention.
10) Any case not described in the indications.
11) Any patient unwilling to cooperate with postoperative instructions;
mental illness, a condition of senility or substance abuse may cause
the patient to ignore certain necessary limitations and precautions
in the implant usage.
12) Any case where the implant components selected for use would be too
large or too small to achieve the successful result.
13) Any case that requires the simultaneous use of elements from different
systems that are made of different metals.
14) Any case in which there is inadequate tissue coverage of the operative
site.
15) Any case in which implant utilization would disturb physiological pro-
cesses.
16) Inadequate bone quality for stable implant fixation (bone resorption,
osteopenia, and/or osteoporosis). This surgical treatment should not be
used in patients with a known hereditary or acquired osteogenesis im-
perfecta or calcification problems.
17) Any case not needing the spine immobilization.
18) Significant anatomical deformity caused by congenital abnormalities.
19) These implants should not be used in children and patients whose spines
are still developing.
20) Spondylolisthesis unable to be reduced to Grade 1.
21) Prior fusion at the level to be treated.
22) Blood supply limitation in the operative site.
23) CAUTION: PLIF, TLIF and ALIF intervertebral implants are not intended
for use in cervical spine.
2. The above-mentioned list of contraindications is not exhaustive.
4