(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.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 anterior lumbar interbody fusion surgery on the lumbar region of his spine from vertebrae l5 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space).Allegedly, "patient's post-operative period has been marked by a period of improvement, followed by increasingly severe mid and low back pain, muscle spasms, and associated radiculopathy in his legs and feet." reportedly, "patient continues to experience chronic mid and lower back pain, muscle spasms, and numbness and tingling in his legs and feet.He also experiences weakness on his left side, and is unable to stand for walk for extended periods.".
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