MAUDE数据库中种植牙不良事件病例报告分析  

Analysis of Adverse Event Case Reports of Dental Implants in the MAUDE Database

作　　者：吕静 LV Jing(Dandong Market Supervision Service Center(Dandong Center for ADR Monitoring),Liaoning Dandong 118002)

机构地区：[1]丹东市市场监管事务服务中心(丹东市药品不良反应监测中心),辽宁丹东118002

出　　处：《中国医疗器械信息》2023年第13期4-6,15,共4页China Medical Device Information

摘　　要：目的:统计并分析人工种植牙不良事件特征,为进一步实施种植牙监测工作提供有力支持。方法:对美国食品药品监督管理局MAUDE数据库2011年1月1日~2021年12月31日人工种植牙不良事件状况进行统计分析,采用描述性的方式,通过Excel电子表格软件对收集到的830份报告进行数据分析,对种植牙安全性作一步探讨。结果:种植牙不良事件报告的主要来源是制造企业,文章统计时间段内2015年发生数最多,共245例,占29.52%。涉及种植体的报告有308例,占37.11%,涉及基台(包括基台固定螺丝)522例,占62.89%。基台(基台固定螺丝)不良事件表现主要为断裂、与种植体分离失败、松动、基台无法嵌入种植体等;种植体不良事件表现主要为骨融合失败、植入物的断裂、移位、松动、变形、脱落等。不良事件主要伤害表现为二次手术造成患者再次痛苦;牙周的发炎、感染、疼痛、不适等。结论:重视种植牙不良事件监测工作,为公众用械安全提供保障。Objective:Statistics and analysis of adverse event characteristics of artificial dental implants,provide strong support for further implementation of dental implants monitoring work.Methods:By conducting statistical analysis on the adverse events of artificial dental implants in the FDA MAUDE database from January 1,2011 to December 31,2021,using a descriptive approach,data analysis was conducted on 830 collected reports using Excel to further explore the safety of dental implants.Results:There were 308 reports involving implants,accounting for 37.11%,and 522 reports involving abutments(including abutment fixing screws),accounting for 62.89%.The main adverse events of the abutment(abutment fixing screws) are fracture,failure to separate from the implants,loosening,and inability to embed the abutment into the implants;The main manifestations of adverse events of implants are bone fusion failure,fracture,displacement,loosening,deformation,and detachment of the implants.The main manifestation of adverse events is secondary surgery causing patient pain again;Periodontal inflammation,infection,pain,discomfort,etc.Conclusion:Pay attention to the monitoring of adverse events during dental implants,and provide guarantees for the safety of public use of equipment.

关 键 词：种植牙 基台 种植体 医疗器械不良事件 分析 

分 类 号：TH787[机械工程—仪器科学与技术]