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
Hematoma (1884); Pain (1994); Ambulation Difficulties (2544)
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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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It was reported that on an unknown date in (b)(6) 2012, the patient underwent surgery of bilateral recess decompression from l2-l3 using rhbmp-2/acs.Patient continued to suffer intense pain and was forced to walk with a cane and had hematoma post surgery.
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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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