FDA MAUDE database analysis of titanium middle ear prosthesis

IF 1.4 Q2 OTORHINOLARYNGOLOGY
Jaclyn Carey, Sairisheel Gabbireddy , Luke Mammen , Gianna Rosamilia , Varun Patel, David Foyt, Steven Parnes
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引用次数: 2

Abstract

Purpose

Partial ossicular replacement (PORP) and total ossicular replacement prostheses (TORP) are used to restore ossicular chain function. Despite favorable auditory outcomes, these interventions have associated risks and complications. This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications, interventions, and root cause analysis (RCA) findings.

Materials and methods

The MAUDE database was searched for Medical Device Reports (MDRs) relating to PORPs and TORPs from 2010 to 2020. MDR event descriptions were reviewed, and adverse events were identified as a device issue, patient issue, and/or packaging issue that occurred intraoperatively or postoperatively.

Results

Our search identified 70 MDRs which included 110 reported adverse events. Events consisted of 63 device issues, often due to device breaks and displacements, 39 patient issues, including common complaints of hearing loss and erosion, and 8 packaging issues. When comparing PORPs and TORPs, TORPs had more reported device issues whereas PORPs had more packaging issues. Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery. For devices returned to the manufacturer, RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.

Conclusion

Device issues were the most common adverse events and frequently required subsequent intervention. Displacement occurred more often with TORPs and was associated with changes in hearing or erosion. The findings of this study are purely descriptive and may not have direct clinical relevance.

Abstract Image

钛合金中耳假体的FDA MAUDE数据库分析
目的采用部分听骨置换术(PORP)和全听骨置换术(TORP)修复听骨链功能。尽管有良好的听觉效果,但这些干预措施有相关的风险和并发症。本研究检查了FDA MAUDE数据库中的听骨链假体不良事件,以突出并发症、干预措施和根本原因分析(RCA)结果。材料与方法检索MAUDE数据库2010 - 2020年与porp和torp相关的医疗器械报告(mdr)。回顾了MDR事件描述,并将不良事件确定为术中或术后发生的器械问题、患者问题和/或包装问题。结果我们的研究确定了70例mdr,其中包括110例报告的不良事件。事件包括63个设备问题,通常是由于设备断裂和移位,39个患者问题,包括听力损失和糜烂的常见投诉,8个包装问题。当比较porp和torp时,torp有更多报告的设备问题,而porp有更多的包装问题。术中装置问题通常通过使用备用装置完成手术来解决,大多数术后装置问题需要额外的手术。对于退回制造商的设备,RCA确定大多数故障是由修改和/或操作不当引起的,或者产品符合规格,但故障原因不明。结论器械问题是最常见的不良事件,经常需要后续干预。移位更常发生在torp中,并与听力变化或糜烂有关。本研究的结果纯粹是描述性的,可能没有直接的临床相关性。
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来源期刊
Journal of Otology
Journal of Otology Medicine-Otorhinolaryngology
CiteScore
2.70
自引率
0.00%
发文量
461
审稿时长
18 days
期刊介绍: Journal of Otology is an open access, peer-reviewed journal that publishes research findings from disciplines related to both clinical and basic science aspects of auditory and vestibular system and diseases of the ear. This journal welcomes submissions describing original experimental research that may improve our understanding of the mechanisms underlying problems of basic or clinical significance and treatment of patients with disorders of the auditory and vestibular systems. In addition to original papers the journal also offers invited review articles on current topics written by leading experts in the field. The journal is of primary importance for all scientists and practitioners interested in audiology, otology and neurotology, auditory neurosciences and related disciplines. Journal of Otology welcomes contributions from scholars in all countries and regions across the world.
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