The researchers conducted a retrospective cohort study at level III. For a study, the researchers sought to offer an unbiased report on the current rate of severe problems for 510(k) cleared sacroiliac joint (SIJ) fusions, as well as to look into the underlying causes of these difficulties. All reported FDA 510(k) cleared SIJ fusion device problems were searched in the Manufacturer and User Facility Device Experience (MAUDE) database. Each report yielded a number of data points, which were recorded. The number of SIJ fusions conducted each year was also looked up in the Hospital Inpatient National Statistics and the Center for Medicare and Medicaid Services (CMS). The initial report was dated June 30, 2011, and the latest report was dated July 28, 2020, according to a review of the MAUDE database. Patient injury was the most common type of event, accounting for 97.5% (1080/1107) of all reported incidents. About 3 patients died, according to the reports (0.3%). The most prevalent device issue was malposition, which accounted for 49.5% (548/1107) of the total. User mistake was the primary cause of these incidents, accounting for 58.2% (644/1107). Revision surgery or reoperation was reported in 92.8% of cases (1028/1107). SIJ fusions exhibited an overall trend of rising yearly SIJ fusions, according to CMS data. The majority of problems reported to MAUDE for FDA-approved SIJ fusion devices were caused by user error due to incorrect implant placement. These complications were likely underreported, and there was currently no formal tracking system in place to assess exact complication and revision rates for entire SIJ fusions. Improved education, training, and oversight could potentially minimize patient injury and healthcare expenses, which were currently inadequate.
