– Not applicable for the USA – See version for the USA –
Side-effects and adverse interactions
The application or improper use of this system carries the follow-
ing risks:
•
Implant failure resulting from excess load
– warping or bending
– loosening
– breakage
•
Inadequate fixation
•
Absence of, or delayed, bony union
•
Infection
•
Fractured vertebral body or bodies
•
Tissue reaction to implant materials
•
Hematoma and impaired wound healing
•
Injuries to
– nerve roots
– spinal cord
– vessels
– organs
•
Changes of the normal spine lordosis
•
Impairment of the gastrointestinal, urological and/or
reproductive systems
•
Pain or indisposition
•
Bursitis
20
4
S
Spinal System