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); Sleep Dysfunction (2517)
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Event Type
Injury
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Event Description
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It was reported that the patient was referred to the doctor in 2010 for lower back pain and pain in her right leg.In (b)(6) 2010, the surgeon performed lumbar spine surgery on the patient in which rhbmp-2/acs was used.Post-op, the patient complained of increased pain and began experiencing new and extreme pain in her hip.The patient had to undergo a hip replacement surgery with another doctor.Reportedly, the patient is unable to stand for long periods of time and can only sleep in certain positions.Her pain persists and allegedly her quality of life has diminished.
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Manufacturer Narrative
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(b)(4).Date of surgery is unknown but it happened in (b)(6) 2010.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Search Alerts/Recalls
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