Madhu Praneethkumar, Hughes Liam P, Azad Tej D, ElNemer William, Shafi Mahnoor, Lubelski Daniel, Theodore Nicholas, Bydon Ali, Witham Timothy
The Johns Hopkins University School of Medicine, Baltimore, United States.
Eur Spine J. 2025 Sep;34(9):4213-4221. doi: 10.1007/s00586-025-09174-4. Epub 2025 Jul 29.
The extreme lateral interbody fusion (XLIF) approach is being increasingly adopted to alleviate complications that are commonplace with other approaches; however, an analysis of the device malfunctions and patient injuries associated with the procedure was not available. The purpose of this study was to search the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE) for medical device reports (MDRs) associated with the XLIF procedure and categorically analyze the device and patient complications.
MDRs from Jan. 2012 to Nov. 2022 from the MAUDE database regarding the XLIF procedure were filtered and analyzed by two independent reviewers. The complications associated with each MDR were then categorized into device malfunctions and patient injuries, further reclassified into intra-operative and post-operative complications, and analyzed for their relative frequencies.
The most common intra-operative device malfunction was the fracture of an instrument other than the interbody/cage at 8.1% (25/308) and the least common intra-operative device malfunction was an inability to insert the interbody/cage at 3.6% (11/308). The most common post-operative device malfunction was migration of something other than the cage at 5.2% (16/208) and the least common was cage migration at 2.3% (7/208). Post-operative wound issues were the most common patient injury at 7.3% (23/314) and the least common injuries included intra-operative paralysis and intra-operative death at 0.6% (2/314).
Although the XLIF procedure was developed to mitigate vascular injury, the predominant complication continues to be vascular injury, followed by organ injury based on MDRs submitted to the MAUDE database. This study provides an extensive search into the device malfunctions and patient injuries specific to the XLIF procedure, which has not been studied before. Such analysis provides a valuable focus for manufacturers and surgeons to improve patient safety by refining device design and optimizing surgical techniques.
极外侧椎间融合术（XLIF）越来越多地被采用，以缓解其他手术常见的并发症；然而，尚无对与该手术相关的器械故障和患者损伤的分析。本研究的目的是在食品药品监督管理局（FDA）的制造商和用户设施器械经验数据库（MAUDE）中搜索与XLIF手术相关的医疗器械报告（MDR），并对器械和患者并发症进行分类分析。
由两名独立的评审人员对MAUDE数据库中2012年1月至2022年11月有关XLIF手术的MDR进行筛选和分析。然后将与每个MDR相关的并发症分为器械故障和患者损伤，进一步重新分类为术中并发症和术后并发症，并分析其相对频率。
最常见的术中器械故障是椎间融合器/椎间融合器以外的器械断裂，占8.1%（25/308），最不常见的术中器械故障是无法插入椎间融合器/椎间融合器，占3.6%（11/308）。最常见的术后器械故障是椎间融合器以外的物体移位，占5.2%（16/208），最不常见的是椎间融合器移位，占2.3%（7/208）。术后伤口问题是最常见的患者损伤，占7.3%（23/314），最不常见的损伤包括术中瘫痪和术中死亡，占0.6%（2/314）。
尽管XLIF手术旨在减轻血管损伤，但根据提交给MAUDE数据库的MDR，主要并发症仍然是血管损伤，其次是器官损伤。本研究对XLIF手术特有的器械故障和患者损伤进行了广泛的搜索，此前尚未有过相关研究。这样的分析为制造商和外科医生提供了一个有价值的关注点，有助于通过改进器械设计和优化手术技术来提高患者安全性。
