(b)(4) (persisting back pain).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, the patient underwent transforaminal lumbar interbody fusion and posterior lumbar fusion from vertebrae l3 to l5.The patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., transverse processes and retrosacral recess).Allegedly, post-op, "the patient continues to experience chronic lower back pain, numbness and tingling in his left leg, tingling in his right toes, and muscle spasms.He must constantly change positions, cannot sit for extended periods, experiences difficulty walking, and requires occasional use of a walker to assist in ambulation.He also suffers from bladder dysfunction and sexual issues.".
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