(b)(4) (persisting back pain).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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
It was reported that on (b)(6) 2015, patient underwent a spine fusion surgery from t10 to l4.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., lateral masses).Despite multiple revision surgeries, the patient continued to experience chronic lower back pain, with pain radiating down to her hips and right leg, numbness in parts of her back and left leg, and paralysis of her right leg.Patient also suffered from bladder and bowel dysfunction.
|