It was reported that the patient underwent a spinal fusion surgery at the cervical region of his spine from vertebrae c5-c6 in which rhbmp-2/acs was used.The post-operative period was marked by pain and a bone mass formation in his cervical spine.The patient subsequently experienced stenosis in his cervical spine.As a result, the patient experienced severe back pain, pain to his arms and legs, tingling sensations in his arms, numbness, and nerve damage.The patient continues to experience severe pain, pain to his arms and legs, tingling sensations in arms, numbness, and nerve damage.
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(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.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.
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