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Related Experiment Video

Updated: Oct 4, 2025

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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
PubMed
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.

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

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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.