(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) 2011, the patient underwent surgery using rhbmp-2/acs.Reportedly, post-op, patient had increased fear of cancer.On (b)(6) 2012 the patient underwent second surgery to correct nerve damage patient allegedly had in the right side.Status post the two surgeries, reportedly the patient had muscle loss in his chest, shoulder, and arms with pain in his arms.Patient could not bend or stand without pain.Patient had nerve damage in his right hand.Patient can no longer work, play or exercise.
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