(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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.
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It was reported that on, (b)(6) 2014, the patient underwent transforaminal lumbar interbody fusion and posterior fusion from vertebrae l3 to l4.The patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space, transverse processes, facet joint, pars).Allegedly, the patient continues to experience chronic lower back pain radiating to his lower extremities, numbness and tingling in his legs, burning in his thighs, and muscle spasms.He experiences difficulty sitting, standing, walking and sleeping due to pain.He requires use of a cane to assist in ambulation.He also suffers from sexual issues.".
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