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FDA MAUDE database analysis of titanium middle ear prosthesis

Journal of Otology 2022年第1期17卷 18-24页

作者： Jaclyn Carey Sairisheel Gabbireddy Luke Mammen Gianna Rosamilia Varun Patel David Foyt Steven Parnes Department of Otolaryngologye Head and Neck Surgery Albany Medical Center43 New Scotland AvenueAlbanyNY12208USA

Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain *** favorable auditory outcomes,these interventions have associated risks and *** study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications,interventions,and root cause analysis(RCA)*** and methods:The MAUDE database was searched for Medical Device Reports(MDRs)relating to PORPs and TORPs from 2010 to *** event descriptions were reviewed,and adverse events were identified as a device issue,patient issue,and/or packaging issue that occurred intraoperatively or ***:Our search identified 70 MDRs which included 110 reported adverse *** 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 *** comparing PORPs and TORPs,TORPs had more reported device issues whereas PORPs had more packaging *** device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional *** 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 ***:Device issues were the most common adverse events and frequently required subsequent *** occurred more often with TORPs and was associated with changes in hearing or *** findings of this study are purely descriptive and may not have direct clinical relevance.

关键词： PORP TORP MAUDE ossicular chain reconstruction Medical devices

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