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.Multiple products 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.
|
It was reported that on (b)(6) 2009 patient presented with diagnosis of degenerative disc disease (ddd) and underwent anterior cervical discectomy and fusion (acdf) -extrapharyngeal anterolateral approach, at levels c3-c4,c4-c5 using rhbmp-2.Onset (b)(6) 2009 , the patient complained of hoarseness (minimal), neck ( incisional wound) swelling, difficulty eating (swallowing).Onset (b)(6) 2009, the patient complained of cough, pain at right side of neck, difficulty swallowing, tingling, right hand (persistent).
|