ChM CHARSPINE system Bedienungsanleitung Seite 5

3 ADVERSE EFFECTS
1. The adverse effects may necessitate reoperation or revision. The surgeon
should warn the patient about the possibility of adverse effects occur-
rence.
2. The below-mentioned list of adverse events is not exhaustive. There is
a risk of occurrence of adverse events with unknown aetiology which may
be caused by many unpredictable factors.
3. Potential adverse events include but are not limited to:
1) Implant damage (fracture, deformation or detachment).
2) Early or late loosening, or displacement of the implant from the initial
place of insertion.
3) Possibility of corrosion as a result of contact with other materials.
4) Body reaction to implants as to foreign bodies e.g. possibility of tumour
metaplasia, autoimmune disease and/or scarring.
5) Compression on the surrounding tissues or organs.
6) Infection.
7) Bone fractures or "stress shielding" phenomenon causing loss of bone
above, below or at the operative site.
8) Haemorrhage and /or hematomas.
9) Pain.
10) Inability to perform everyday activities.
11) Mental condition changes.
12) Death.
13) Deep vein thrombosis, thrombophlebitis.
14) Occurrence of respiratory complications, e.g.: pulmonary embolism, at-
electasis, bronchitis, pneumonia, pulmonary infection, disturbed lung
growth, respiratory acidosis, etc.
15) Scar formation that could cause neurological impairment, or nerves
compression and /or pain.
16) Cessation of any potential growth of the operated portion of the spine.
17) Fracture, microfracture, resorption, damage, or penetration of any spinal
bone (including the sacrum, pedicles, and/or vertebral body) and/or bone
graft or bone graft harvest site at, above, or below the level of surgery.
Retropulsed graft.
18) Loss of neurological function, appearance of radiculopathy, dural tears,
and/or development of pain. Neurovascular compromise, including
paralysis, temporary or permanent retrograde ejaculation in males,
or other types of serious injuries. Cerebral spinal fluid leakage.
19) Herniated nucleus pulposus, disc disruption or degeneration at, above,
or below the level of surgery.
20) Urinary retention, urinary incontinence, or other types of urological sys-
tem compromises.
21) Reproductive system compromise, including infertility, loss of consor-
tium and sexual dysfunction.
22) Gastrointestinal system compromise.
23) Late bone fusion or no visible fusion mass and pseudoarthrosis.
24) Loss of proper spinal curvature, necessity to make corrections, change
of patient' s height, shortening of the spine.
25) Loss of or increase in spinal mobility or function.
26) Bone graft donor site complication.
27) Discitis, arachnoiditis, and/or other types of inflammation.
28) CAUTION: The potential risk of adverse events occurrence as a result
of movement or lack of stabilization may increase in the cases where
associated supplemental fixation systems are not employed.
4 WARNINGS
1. The important medical information provided in this document should be
given to the patient.
2. The selection of proper shape and size of the implant appropriate
for a specific patient is crucial to achieve the success of the surgery.
The surgeon is responsible for this choice.
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