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.
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.