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NA 0550Recalls & reported problems

Medtronic Xomed, Inc. · PROSTHESIS 0550 FLEX H/A PARTIAL 4MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681490024426), received between Aug 14, 2019 and Aug 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 14, 2019Break; Break

    THE HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT AFTER THE PHYSICIAN CUT THE ROD OF THE PROSTHESIS DURING THE PROCEDURE AND WHEN THEY WERE ABOUT THE PUT THE PROSTHESIS IN THE EAR, THE PROSTHESIS WAS BROKEN. THERE WAS NO DAMAGED AND NO BROKEN PIECES REMAIN INSIDE THE PATIENTS BODY. THERE WAS NO DELAY WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8893069 ↗

Other REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL devices

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