(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.Multiple products 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.
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It was reported that on (b)(6) 2010, the patient underwent a posterior lumbar interbody fusion surgery on the lumbar region of his spine from vertebrae l4 to l5 using rhbmp-2."the rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space)." post-op the patient allegedly had increasing low back pain and radiculopathy into his lower extremities." reportedly, "the patient continues to experience constant low back pain, with radiating pain down his legs, numbness in his left leg and in both feet, and swelling in his legs.He experiences difficulty sitting, standing and walking, and cannot stay in the same position for extended periods.Patient also suffers from bladder dysfunction.".
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