MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); Dyspnea (1816); Dysphasia (2195)
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Event Type
Injury
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Event Description
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It was reported that patient was suffering from a deteriorated disc in cervical spine.The patient underwent a cervical fusion and disc replacement from c3-c6.The patient was implanted with rhbmp-2/acs.Post-op, the patient had continued to lose his ability to speak with greater frequency and duration.Also the patient had trouble in swallowing, clearing his throat, and suffered from persistent coughing that impedes patient's ability to breathe.
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Manufacturer Narrative
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(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Search Alerts/Recalls
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