FDA MAUDE database analysis of titanium middle ear prosthesis
| Autor: | Jaclyn Carey, Varun Patel, Luke Mammen, Steven M. Parnes, Gianna Rosamilia, David Foyt, Sairisheel R. Gabbireddy |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Ossicular chain
medicine.medical_specialty business.industry Hearing loss Database analysis medicine.medical_treatment Psychological intervention Prosthesis Surgery Ossicular chain reconstruction PORP medicine.anatomical_structure MAUDE Otorhinolaryngology RF1-547 Middle ear Medicine Medical devices medicine.symptom TORP business Adverse effect Root cause analysis |
| Zdroj: | Journal of Otology, Vol 17, Iss 1, Pp 18-24 (2022) |
| ISSN: | 2524-1753 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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