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 Problem
Loss of Range of Motion (2032)
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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 (b)(6) 2005, the patient underwent a posterior spinal fusion surgery.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery and the patient has increased fear of cancer.Allegedly, "the patient is unable to play any contact sports or engage in physical activities.The patient has limited range of motion as a result of the surgery.".
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Search Alerts/Recalls
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