Rahl Michael D, Weistroffer Joseph, Dall Bruce E
Department of Orthopaedic Surgery, Western Michigan University School of Medicine, Kalamazoo, MI.
Clin Spine Surg. 2022 Apr 1;35(3):E363-E367. doi: 10.1097/BSD.0000000000001264.
This was a level III-retrospective cohort study.
The objective of this study was to present an unbiased report of the current rate of severe complications for Federal Drug Administration (FDA) 510(k) cleared sacroiliac joint (SIJ) fusions and investigate the underlying cause of these complications.
The number of yearly SIJ fusions is on an upward trend. Currently, the most utilized implants to fuse the SIJ have been FDA 510(k) cleared devices. Studies reporting on complications following SIJ fusions are mostly industry-sponsored.
The Manufacturer and User Facility Device Experience (MAUDE) database was searched for all reported FDA 510(k) cleared SIJ fusion device complications. Several data points were obtained from each report and recorded. The Hospital Inpatient National Statistics and the Center for Medicare and Medicaid Services (CMS) was also searched for the number of SIJ fusions performed each year.
A search of the MAUDE database returned 1115 reports, with the first report on June 30, 2011, and the last report on July 28, 2020. Patient injury was the most common type of event reported at 97.5% (1080/1107). Death was reported in 3 patients (0.3%). Malposition was the most common device problem at 49.5% (548/1107). The root cause of these events was primarily user error at 58.2% (644/1107). Revision surgery or reoperation occurred in 92.8% (1028/1107) of reports. Data for SIJ fusions through CMS showed an overall trend of increasing yearly SIJ fusions.
The majority of complications reported to MAUDE for FDA 510(k) cleared SIJ fusion devices are user error due to improper placement of implants. These complications are likely underreported, and there is currently no formal tracking system of total SIJ fusions performed to calculate accurate complication and revision rates. Patient injury and health care costs can potentially be reduced with improved education, training, and oversight, which is currently lacking.
这是一项三级回顾性队列研究。
本研究的目的是对美国食品药品监督管理局（FDA）510(k)批准的骶髂关节（SIJ）融合术当前的严重并发症发生率进行无偏报告，并调查这些并发症的潜在原因。
每年SIJ融合术的数量呈上升趋势。目前，用于融合SIJ的最常用植入物是已获FDA 510(k)批准的器械。关于SIJ融合术后并发症的研究大多由行业赞助。
在制造商和用户设施设备经验（MAUDE）数据库中搜索所有报告的已获FDA 510(k)批准的SIJ融合设备并发症。从每份报告中获取并记录了几个数据点。还在医院住院患者国家统计数据以及医疗保险和医疗补助服务中心（CMS）中搜索了每年进行的SIJ融合术数量。
对MAUDE数据库的搜索返回了1115份报告，第一份报告日期为2011年6月30日，最后一份报告日期为2020年7月28日。患者受伤是报告的最常见事件类型，占97.5%（1080/1107）。有3名患者报告死亡（0.3%）。位置不当是最常见的器械问题，占49.5%（548/1107）。这些事件的根本原因主要是用户错误，占58.2%（644/1107）。92.8%（1028/1107）的报告中进行了翻修手术或再次手术。通过CMS获得的SIJ融合术数据显示，每年SIJ融合术总体呈上升趋势。
向MAUDE报告的已获FDA 510(k)批准的SIJ融合设备的大多数并发症是由于植入物放置不当导致的用户错误。这些并发症可能报告不足，目前没有用于计算准确并发症和翻修率的SIJ融合术总数的正式跟踪系统。通过改善教育、培训和监督（目前缺乏这些方面），有可能降低患者受伤情况和医疗保健成本。
