(b)(4).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) 2008, patient underwent a video assisted thoracic surgery, anterior release with cage insertion and fusion from t4-t5 to t11-t12, followed by percutaneous posterior spinal fusion with instrumentation of t3-l1.During the surgery, rhbmp-2/acs was implanted in the patient.Post-op, patient has constant pain in her upper back, pain behind her shoulder blades and adjacent to her spine, constant neck and back stiffness, trouble swallowing, inflammation in the esophagus, numbness of the upper back and tailbone region, sciatic nerve pain, muscle spasms, headaches, and arm weakness.Patient also suffers from anxiety and depression and has difficulty with washing dishes, sweeping, and folding laundry.Patient has an increased fear of cancer.
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