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
Unspecified Infection (1930); Pain (1994); Swelling (2091)
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Event Type
Injury
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on (b)(6) 2009, patient was implanted with rhbmp-2.Initial diagnosis: acdf for treatment of degenerative disc disease.Implant level (s): c5-c6,c6-c7 procedure: anterior cervical discectomy and fusion (acdf)- extrapharyngeal anterolateral approach c26726 on (b)(6) 2009 the patient reported sinus infection (drainage and cough).On (b)(6) 2009, the patient reported discomfort in back of neck.On (b)(6) 2009- swelling at surgical incision site.On (b)(6) 2010- shoulder pain (bursitis).
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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