(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) 2009, the patient underwent cervical fusion at levels c4-5 wherein rhbmp-2/acs was implanted from a posterior approach in the facet joints.Post-op, the patient had increasing neck pain, with radiculopathy in her upper extremities.The patient continued to experience extreme neck pain, with pain radiating down spine, radiculopathy in her upper extremities, weakness in her hands, difficulty breathing, and difficulty swallowing.She required a cane for assistance in ambulation.
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