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
Dysphagia/ Odynophagia (1815); Swelling (2091)
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Event Date 04/30/2014 |
Event Type
Injury
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Event Description
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It was reported in a publication that 72 consecutive patients were treated with a multi-level acdf using cornerstone hsr and rhbmp-2/acs.Major complications occurred in 5 patients: 2 returns to the or (1 nonunion, 1 seroma), 1 recurrent laryngeal nerve injury, and 2 hospital readmissions for excessive pre-vertebral swelling/dysphagia treated with steroids and observation.Minor complications occurred in 3 patients: 2 exacerbations of pre-existing medical conditions (1 atrial fibrillation, 1 copd), and 1 hospital readmission for nausea/headache due to narcotics.Two patients were readmitted to the hospital for excessive pre-vertebral swelling/dysphagia treated with steroids and observation.
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Manufacturer Narrative
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Article citation: khajavi et al.Safety and efficacy of bioabsorbable cervical spacers and rhbmp-2 for multilevel acdf.Abstract of the international society for the advancement of spine surgery (isass) 2014, 30-apr to 02-may, miami usa.Mean age 55 yrs.71% female.Implant date: between 2007-2012.(b)(6).(b)(4).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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Search Alerts/Recalls
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