(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) 2012, the patient underwent anterior 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 posterolateral gutters).Allegedly, post-op, "the patient continues to experience chronic lower back pain, with pain radiating down into his legs, muscle spasms in both thighs, tingling in both feet, and numbness extending from his right knee to his right ankle.He experiences difficulty sitting, standing and walking for extended periods, and difficulty sleeping due to pain.Patient also suffers from sexual issues and depression.".
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