(b)(6).(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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It was reported that on (b)(6) 2005, the patient underwent three stage anterior and posterior cervical fusion surgery from vertebrae c6-c7, stage ii, posterior cervical fusion, was performed on (b)(6) 2005, and stage iii, anterior cervical fusion, was performed on (b)(6) 2005 wherein rhbmp-2/acs was implanted.The rhbmp-2 collagen sponge was placed outside a cage (i.E in the lamina area and over the spinous processes).Post-op, the patient complained of increasingly neck pain, radiating pain, and throat symptoms.The patient continued to experience chronic neck pain, with radiating throughout his body, difficulty speaking and swallowing, choking, and bladder dysfunction.These injuries prevent patient from practicing and enjoying the activities of daily life.
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