Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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It was reported that on (b)(6) 2010, the patient underwent l1-l3 fusion with instrumentation.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery and the patient has increased fear of cancer.Allegedly, "the patient continued experiencing pain and the pain was worse than before the surgery.The patient is on disability, has trouble sleeping, standing, and sitting and can no longer engage in activities that once brought him great joy.".
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