Filan Jack, Bowey Andrew, Joyce Thomas
School of Medical Education, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK.
Great North Children's Hospital, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
Ther Innov Regul Sci. 2025 Jan;59(1):31-40. doi: 10.1007/s43441-024-00724-4. Epub 2024 Nov 13.
MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X.
Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis.
1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0 mm or > 5.0 mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation.
These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported.
磁力扩展控制（MAGEC）棒可避免脊柱侧弯患者反复进行延长手术。然而，已发布多项《现场安全通知》，包括因致动器端盖分离而进行的全球产品召回。我们旨在回顾向美国食品药品监督管理局（FDA）报告的有关MAGEC棒的不良事件，重点关注MAGEC X。
使用R统计软件访问并分析提交至制造商和用户设施设备经验数据库的与MAGEC设备相关的报告。排除标准包括重复报告和文献综述报告（n = 54）。使用归纳性内容分析法分析自由文本数据。
截至2023年11月30日，共报告了1016起不良事件。其中99.0%（1006起）由制造商提交。报告主要来自英国（465起，45.8%）或美国（421起，41.4%）。从自由文本数据来看，最常见的不良事件是撑开机制故障（573起）、器械磨损（272起）和致动器密封损坏（180起）。棒体骨折（n = 48）与棒体直径（≤5.0 mm或>5.0 mm）无显著相关性，p = 0.736。234份报告提及了MAGEC X设备；其中41.9%（99份）发现有致动器端盖分离。其他事件包括撑开故障（63起）、表面损坏（31起）和棒体骨折（15起）。2020年6月30日，MAGEC X2获得FDA批准。20份报告提及在此日期之后生产的设备，7份描述了撑开机制故障；值得注意的是，没有端盖分离的报告。
这些数据代表了所报告的关于MAGEC棒的最大规模不良事件系列，包括有关MAGEC X的重要新数据。除端盖分离外，还报告了撑开故障、表面损坏和棒体骨折。
