The Taylor Collaboration, San Francisco, CA.
Department of Orthopaedic Surgery, SF Orthopaedic Residency Program, St. Mary's Medical Center, San Francisco, CA.
Spine (Phila Pa 1976). 2023 Dec 1;48(23):1652-1657. doi: 10.1097/BRS.0000000000004583. Epub 2023 Jan 23.
A retrospective case series.
This study aims to assess the rates of lumbar interbody cage failures based on their material and manufacturer.
Perioperative lumbar interbody cage malfunctions are underreported events in the spine literature and may result in complications. Although the Food and Drug Administration ensures the safety of these devices under physiological conditions after implantation, these devices may experience nonphysiological conditions during implantation, which may be overlooked.
The MAUDE database was examined for reports of lumbar cage device malfunctions from 2012 to 2021. Each report was categorized based on failure type and implant design. A market analysis was performed by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the United States. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index.
Overall, 1875 lumbar cage malfunctions were identified. Of these, 1230 (65.6%) were cage breakages, 257 (13.7%) were instrument malfunctions, 177 (9.4%) were cage migrations, 143 (7.6%) were assembly failures, 70 (4.5%) were screw-related failures, and 21 (1.1%) were cage collapses. Of the breakages, 923 (74.9%) occurred during insertion or impaction and 97 entries detailed a medical complication or a retained foreign body. Of the migrations, 155 (88.6%) were identified postoperatively, of which 73 (47.1%) detailed complications and 52 (33.5%) required a revision procedure. Market analysis demonstrated that Medtronic, Zimmer Biomet, Stryker, Seaspine, and K2M exceeded the calculated threshold.
Lumbar cages with polyether ether ketone core material failed more frequently by breakage, whereas titanium surface cages failed more frequently by migration. Failure rates varied depending on the manufacturer. Most cage breakages identified in the present study occurred intraoperatively during implantation. These findings call for a more detailed Food and Drug Administration evaluation of these intraoperative malfunctions before commercial approval.
Level 4.
回顾性病例系列研究。
本研究旨在根据材料和制造商评估腰椎椎间融合器失败的发生率。
脊柱文献中，围手术期腰椎椎间融合器故障的报告较少，可能导致并发症。尽管食品和药物管理局在植入后确保这些设备在生理条件下的安全性，但这些设备在植入过程中可能会经历非生理条件，而这些条件可能会被忽视。
检查 MAUDE 数据库，以获取 2012 年至 2021 年腰椎 cage 设备故障的报告。根据故障类型和植入物设计对每份报告进行分类。通过将每个制造商每年的总故障数除以其在美国脊柱植入物的近似年收入，进行市场分析。进行异常值分析，以生成一个阈值，超过该阈值则定义为失败率高于正常指数。
总体而言，共发现 1875 例腰椎 cage 故障。其中，1230 例（65.6%）为 cage 断裂，257 例（13.7%）为器械故障，177 例（9.4%）为 cage 移位，143 例（7.6%）为组件故障，70 例（4.5%）为螺钉相关故障，21 例（1.1%）为 cage 塌陷。在断裂中，923 例（74.9%）发生在插入或冲击过程中，97 个条目详细说明了医疗并发症或残留异物。在移位中，155 例（88.6%）在术后发现，其中 73 例（47.1%）详细说明了并发症，52 例（33.5%）需要进行修订程序。市场分析表明，美敦力、捷迈邦美、史赛克、海斯谱和 K2M 超过了计算得出的阈值。
聚醚醚酮芯材的腰椎 cage 更容易发生断裂，而钛表面 cage 更容易发生迁移。失败率取决于制造商。本研究中大多数识别出的 cage 断裂发生在植入过程中的手术室内。这些发现呼吁食品和药物管理局在商业批准前对这些手术期间的故障进行更详细的评估。
4 级。
