与Barricaid环形关闭装置相关的不良事件:对FDA MAUDE数据库的分析
Haiyue Jin1, Ryan Hoang2, Arthur W Cowman2
1Department of Neurosurgery, School of Medicine, The University of California, Irvine, CA, USA.
Journal of craniovertebral junction & spine
|December 11, 2025
概括
用于预防脊椎手术后重新结的巴里卡德装置经历了迁移和植入失败等故障. 复仍然是一个显著的不良事件,需要在设备设计和患者选择方面进一步改进.
科学领域:
- 脊柱外科手术 脊柱外科手术
- 医疗器械安全 医疗器械安全
- 生物材料和植入物 生物材料和植入物
背景情况:
- 该 Barricaid环状闭塞装置旨在防止在腰椎切除术后出现大环状缺陷的患者的再.
- 关于该设备的患者安全概况的数据有限.
- 本研究旨在分析设备故障和不良事件,以确定需要改进的领域.
研究的目的:
- 为了评估 Barricaid 环形关闭装置的安全性和性能.
- 为了识别常见的设备故障和相关的不良事件.
- 为提高患者安全和设备有效性提供建议.
主要方法:
- 从FDA MAUDE数据库 (2020年1月至2025年2月) 检索了Baricaid设备的101个不良事件报告.
- 记录事件日期,设备类型,故障细节和不良事件结果.
- 分析数据以确定故障和不良事件的频率和类型.
主要成果:
- 设备迁移 (30.7%) 和植入不成功 (26.7%) 是最常见的故障.
- 与设备相关的最常见的不良事件 (36.6%) 是再化.
- 在66.3%的报告中进行了修复手术,通常涉及设备移除 (45.5%).
结论:
- 设备故障和不良事件凸显了需要仔细选择患者和改进设备设计的需要.
- 患者的脆弱性和并发症等因素可能会增加患病率和重新手术的风险.
- 持续的营销后监测和设备改进对于降低风险至关重要.
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