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
Ossification (1428); Dysphagia/ Odynophagia (1815); Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported in a literature article titled ¿short, segmental, stacked, individual anterior cervical plates reduce pseudarthrosis rates in multi-level anterior cervical discectomy and fusion surgery¿ that dysphagia, pseudoarthrosis, loss of lordosis and ossification was reported for unknown number of patients that underwent surgery using rhbmp-2.
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Manufacturer Narrative
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Information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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