(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.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.
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It was reported that on (b)(6) 2012, patient underwent a transforaminal lumbar interbody fusion and posterolateral fusion surgery at l3-l5.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and posterior elements).Reportedly, "patient's post-operative period has been marked by a period of improvement, followed by increasing low back and left leg pain.Patient continues to experience chronic pain in his neck, upper back, lower back, shoulders arms, and hands.He experiences difficulty swallowing, breathing and speaking, and swelling in his neck and upper back.As a result of numbness in hands, he experiences loss of grip, and is constantly dropping things.".
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