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
Pain (1994); Loss of Range of Motion (2032); 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.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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Event Description
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Pre-op diagnosis: instability in cervical spine procedure: fusion implant date: (b)(6) 2011 (month and year valid) it was reported that: on an unknown date in (b)(6) 2011 the patient underwent c1-c2 cervical fusion surgery using rhbmp-2.Post-op, the patient noticed that she was having pain.After surgery, patient was bedridden for weeks, her recovery was long and painful.Before the surgery patient did not have any pain; now patient has pain in her neck and head, she has lost mobility, has difficulty sleeping, and is limited in the activities that she can perform.On unknown dates the patient had brief office visits for post-operative care.
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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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