(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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Procedure: posterior lumbar interbody fusion surgery, an anterior lumbar interbody fusion surgery, and a posterior lumbar interbody fusion and posterolateral fusion surgery levels implanted: l5-s1 it was reported that on on (b)(6) 2008, the patient underwent spine fusion surgery from vertebrae l4-s1 wherein rhbmp-2/acs was implanted with posterior approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the disc space).Despite two revision surgeries, patient continued to experience constant and extreme low back pain radiating to his legs, swelling in his lower back, radiculopathy, and numbness/ tingling in legs.The patient experienced difficulty in sitting, standing and walking, and required occasional use of a cane.
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