(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.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.
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It was reported per a clinical study that on (b)(6) 2009, the patient underwent anterior cervical discectomy and fusion (acdf) for treatment of degenerative disc disease at levels c5-6, c6-7.The patient was implanted with rhbmp-2/acs in this surgery.On (b)(6) 2009, patient presented with pain in neck and interscapular area, characterized as "burning", "pulsing".Also complained of sore surgical incision.On (b)(6) 2009, patient presented with pain in neck, radiating to right shoulder.On (b)(6) 2009, patient presented with ache at right side of neck.On (b)(6) 2010, patient presented with dysesthesia, paresthesias (numbness, tingling) both hands <(>&<)> forearms.
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