(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) 2009, patient underwent a spinal fusion surgery with instrumentation and rhbmp-2/acs at l4-s1.Reportedly, patient has fear of cancer after surgery.Immediately after the surgery, patient began experiencing pain and was unable to sit-up and was bed-ridden for weeks.Four months after the surgery patient started walking without assistance of the walker.Per surgeon, patient¿s overweight attributed to slow progress.Patient started treating with a pain specialist from 2010 till date.As reported, patient still has severe back pain and is unable to perform everyday tasks like cooking and cleaning and patient could not return to work after surgery due to pain.
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