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McGee 1156213Recalls & reported problems

Medtronic Xomed, Inc. · PROSTHESIS 1156213 MCGEE MOD .5X4.5MM · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681490035200), received between May 30, 2023 and May 30, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hearing Impairment1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT.

    Patient problems: Hearing Impairment

    MAUDE report 17021376 ↗

Other PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT devices

All PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.