(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) 2015, patient underwent transforaminal lumbar interbody fusion surgery on the lumbar region of his spine from vertebrae l4 to l5.Reportedly, rhbmp-2/acs was used in this surgery.Despite two revision surgeries, patient continued to experience chronic back pain, with pain radiating to his legs, numbness and tingling in both legs, cramping in both legs, and right foot drop.Patient could not sit or stand for extended periods and requires a use of a back brace, cane, and walker on occasion.He also experienced difficulty sleeping and fatigue.
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