(b)(4).Notes: 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 patient underwent revision surgery on (b)(6) 2013.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral gutters).Despite revision surgery, reportedly, "patient continues to experience chronic lower back pain, with pain radiating down her left hip and leg, and numbness and tingling in her left leg.Patient has difficulty sitting, standing and walking due to pain, and she also suffers from bladder and bowel issues.".
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