FDA MAUDE database analysis of titanium middle ear prosthesis
Jaclyn Carey1, Sairisheel Gabbireddy1, Luke Mammen1
1Department of Otolaryngology- Head and Neck Surgery, Albany Medical Center, 43 New Scotland Avenue, Albany, NY, 12208, USA.
Journal of Otology
|February 10, 2022
Summary
Adverse events with ossicular replacement prostheses, including partial ossicular replacement (PORP) and total ossicular replacement prostheses (TORP), are primarily device-related, often requiring further surgery. TORPs showed more displacement issues, while PORPs had more packaging problems.
Area of Science:
- Otolaryngology
- Medical Device Safety
- Surgical Outcomes
Background:
- Ossicular chain reconstruction using partial ossicular replacement prostheses (PORPs) and total ossicular replacement prostheses (TORPs) aims to improve hearing.
- Despite successful auditory restoration, these devices carry risks of complications and adverse events.
Purpose of the Study:
- To analyze adverse events associated with PORPs and TORPs using the FDA MAUDE database.
- To identify common complications, interventions, and root causes of failures for these prostheses.
Main Methods:
- A retrospective review of Medical Device Reports (MDRs) for PORPs and TORPs from 2010-2020 was conducted.
- Adverse events were categorized into device, patient, and packaging issues, occurring intraoperatively or postoperatively.
Main Results:
- 110 adverse events were identified across 70 MDRs, with device issues (63) being most frequent, including breaks and displacements.
- TORPs experienced more device issues, whereas PORPs had more packaging issues. Postoperative device issues often necessitated revision surgery.
- Root cause analysis of returned devices indicated breaks due to modification/mishandling or undetermined causes.
Conclusions:
- Device-related issues are the most common adverse events for ossicular prostheses, frequently requiring surgical intervention.
- TORP displacement was linked to hearing changes and erosion. Findings are descriptive and may lack direct clinical applicability.
Keywords:
FDA, U.S. Food and Drug AdministrationMAUDEMAUDE, Manufacturer and User Facility Device ExperienceMDR, Medical device reportMedical devicesOCR, Ossicular chain replacementOssicular chain reconstructionPORPPORP, Partial ossicular replacement prosthesisRCA, Root cause analysisTORPTORP, Total ossicular replacement prosthesis
