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
Ossification (1428); Atrial Fibrillation (1729); Neuropathy (1983); Injury (2348); Cancer (3262)
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Event Type
Injury
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Manufacturer Narrative
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Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.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, post-op, patient allegedly complained of radiculitis, radiculopathy, chronic pain requiring narcotics, ectopic bone growth orcyst, adjacent segment disease, nerve injury or damage, muscle and soft tissue injury or damage, atrial fibrillation, skin cancer, ossification of adjacent soft tissues of the lumbar spine.
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Manufacturer Narrative
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Additional information: patient race.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 the patient underwent anterior and posterior decompression at l4-s1, fusion and instrumentation.Post-op, the patient allegedly also experienced inflammation, post-operatively, had uro-genital pain for about one year after lumbar fusion surgery, erectile dysfunction, stomach hernia attributable to nerve injury, atrial fibrillation secondary to excessive stress from chronic pain, two skin cancers, and severe emotional distress.The patient underwent cryoablation surgery for atrial fibrillation in (b)(6) 2017 and left hip replacement surgery in (b)(6) 2016.
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Search Alerts/Recalls
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