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). 2024 Apr 15;49(8):553-560. doi: 10.1097/BRS.0000000000004638. Epub 2023 Mar 27.
Retrospective case series.
To characterize failure rates of cervical cages based on manufacturer and design characteristics using the nationwide database of reported malfunctions.
The Food and Drug Administration (FDA) aims to ensure the safety and efficacy of cervical interbody implants postimplantation; however, intraoperative malfunctions may be overlooked.
The FDA's Manufacturer and User Facility Device Experience database was queried for reports of cervical cage device malfunctions from 2012 to 2021. Each report was categorized based on the failure type, implant design, and manufacturer. Two market analyses were performed. First, "failure-to-market share indices" were generated by dividing the number of failures per year for each implant material by its yearly US market share in cervical spine fusion. Second, "failure-to-revenue indices" were calculated by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the US. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index.
In total, 1336 entries were identified, and 1225 met the inclusion criteria. Of these, 354 (28.9%) were cage breakages, 54 (4.4%) were cage migrations, 321 (26.2%) were instrumentation-related failures, 301 (24.6%) were assembly failures, and 195 (15.9%) were screw failures. Poly-ether-ether-ketone implants had higher failure by market share indices for both migration and breakage compared with titanium. Upon manufacturer market analysis, Seaspine, Zimmer-Biomet, K2M, and LDR exceeded the failure threshold.
The most common cause of implant malfunction was breakage. Poly-ether-ether-ketone cages were more likely to break and migrate compared with titanium ones. Many of these implant failures occurred intraoperatively during instrumentation, which underscores the need for FDA evaluation of these implants and their accompanying instrumentation under the appropriate loading conditions before commercial approval.
回顾性病例系列。
利用报告故障的全国数据库，根据制造商和设计特点，确定颈椎笼的失败率。
食品和药物管理局（FDA）旨在确保颈椎植入物植入后的安全性和有效性；然而，术中故障可能会被忽视。
对 FDA 的制造商和用户设施设备体验数据库进行了查询，以获取 2012 年至 2021 年颈椎笼设备故障的报告。每个报告都根据故障类型、植入物设计和制造商进行了分类。进行了两项市场分析。首先，通过将每年每种植入材料的故障数除以其在颈椎融合中的年美国市场份额，生成“故障市场份额指数”。其次，通过将每年每个制造商的总故障数除以其在美国脊柱植入物的近似年收入，计算“故障收入指数”。进行了异常值分析，以生成一个阈值，高于该阈值的故障率被定义为高于正常指数。
共确定了 1336 项条目，其中 1225 项符合纳入标准。其中，354 项（28.9%）为笼破裂，54 项（4.4%）为笼迁移，321 项（26.2%）为器械相关故障，301 项（24.6%）为装配故障，195 项（15.9%）为螺钉故障。聚醚醚酮植入物的迁移和破裂的市场份额指数均高于钛。在制造商的市场分析中，Spine、Zimmer-Biomet、K2M 和 LDR 超过了故障阈值。
最常见的植入物故障原因是破裂。聚醚醚酮笼比钛笼更容易破裂和迁移。这些植入物故障中的许多发生在手术过程中器械操作期间，这突显出需要在商业批准前，由 FDA 根据适当的加载条件对这些植入物及其配套器械进行评估。
