It was reported that a matched cohort of 52,259 patients undergoing thoracolumbar fusion surgery from 2006 to 2010 in the united states was identified in the market-scan database.Patients without bmp treatment (n=34,840) were matched 2-to-1 to patients receiving bmp (n=17,455).1600 pts underwent anterior procedures, 11912 underwent posterior decompression, and 16237 had posterior instrumentation.2762 patients had complications within 30 days of surgery.Rates of hematoma, pulmonary complications, pe, neurological complications, new malignancy, 30-day readmission rate, mortality at in dex procedure, mortality at 30 ¿day follow up, retrograde ejaculation, infertility, and antidepressant prescription were not statistically significantly different between the bmp treatment and the control groups.There were statistically significantly higher rates of infection, wound dehiscence, and wound complications in the control group.2 patients died within 30 days of the index procedure.
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Article citation: veeravagu et al.The use of bone morphogenetic protein in thoracolumbar spine procedures: analysis of the market-scan longitudinal database.The spine journal (2014).Doi: 10.1016/j.Spinee.2014.05.010.Mean age 53.5 yrs.10049 females, 7406 males.Date of death unknown.2006-2010.Not reported.(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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