(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 that on : (b)(6) 2010, the patient underwent acdf at levels c5-6, c6-7 for treatment of degenerative disc disease (ddd) using rhbmp-2.On (b)(6) 2010, patient presented with sloughing of oral membranes.On (b)(6) 2010, patient presented with incisional swelling ,pain- neck, back pain , pain in shoulders and dysphagia ,paresthesias (numbness, tingling) in both hands.On (b)(6) 2010, patient presented with pain, thoracic area; predates acdf, managed nonoperatively in the past.On (b)(6) 2010, patient presented with pain, right shoulder radiating to axilla.On (b)(6) 2011, patient presented with hands feel swollen, less dexterous (b)(6) 2011, patient presented with worsening of pre-existing thoracic pain, attributed by patient to recent exertion (riding 4-wheeler, hunting).
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