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
Hyperglycemia (1905); Pain (1994); Swelling (2091); Tingling (2171); Numbness (2415)
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Event Date 12/03/2009 |
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.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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Event Description
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As reported , on (b)(6) 2009 the patient underwent anterior cervical discectomy and fusion - extrapharyngeal anterolateral approach for treatment of degenerative disc disease where rhbmp-2 was used at levels c5-c6, c6-c7.Onset (b)(6) 2009- hyperglycemia in patient w/history of diabetes, exacerbated by post-op steroids.The patient was hospitalized for two days until hyperglycemia resolved.Onset (b)(6) 2009- patient was observed for incisional swelling , dysesthesias / parasthesias (pain, numbness, tingling) in the neck and arm.
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Event Description
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It was reported that on: (b)(6) 2009, patient got discharged from hospital after recovering from hyperglycemia.On (b)(6) 2010, patient condition was improved and swelling, dysesthesias/parasthesias (pain, numbness, tingling) in the neck and arm were resolved.
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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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