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.
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.
Insights
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.
