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
Hiccups (1899); Swelling (2091); Tingling (2171); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
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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.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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It was reported ,in a clinical study, that on (b)(6) 2010, patient presented with degenerative disc disease (ddd) and underwent anterior cervical discectomy and fusion surgery for levels c4-c5, c5-c6, c6-c7 where rhbmp-2 was implanted in the patient.On (b)(6) 2011, the patient presented with primary diagnosis: pain at the base of neck posteriorly, sometimes radiating to upper back <(>&<)> right arm with painful, involuntary right arm muscle contractions.
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Event Description
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It was reported that on: (b)(6) 2011, the patient presented for diagnostic test: ap <(>&<)> lateral cervical spine films.Results: normal (b)(6) 2011, the patient presented for diagnostic test: mri w/o contrast, cervical spine.Results: normal.(b)(6) 2012, the patient presented with low back pain.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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