There is no known malfunction of the implanted devices or any information suggesting difficulty in initial placement of the construct.It is unknown if the patient followed post-operative care instructions.No root cause has not been determined and no conclusion can be drawn; information suggests community-acquired infection.Product labeling indicates: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, and vascular or visceral injury, metal sensitivity or allergic reaction to a foreign body, infection".Device not returned.
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