MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Ossification (1428); Pneumonia (2011)
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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 via medwatch (mw5082855) that according to a case study, in which 15 human patients were involved had undergone combination of rhbmp-2 and assembled components following anterior cervical corpectomy and fusion (accf).One patient suffered fatality (death) following post-op aspiration pneumonia.Another patient required posterior revision surgery following post-op graft (device) migration.In the third case, excess bone growth was observed.
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Search Alerts/Recalls
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