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Phonak 063-0500-01Recalls & reported problems

Sonova AG · Phonak Virto M50-312 · Class 2

All models of PHONAK (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 07613389276626), received between Apr 27, 2022 and Apr 27, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DUE TO AN ACCIDENT THE PATIENT REPORTEDLY EXPERIENCED A FORCEFUL IMPACT ON THE RIGHT EAR WHILE THE DEVICE WAS IN USE. THE DEVICE HAS BEEN DAMAGED AND FORCED INTO THE EAR CANAL. THE PATIENT REQUIRED A SURGICAL INTERVENTION TO REMOVE THE DEVICE AND RECONSTRUCT THE EAR CANAL. THE PATIENT REPORTEDLY HEALED FROM THE MEDICAL INTERVENTION AND ENT HAS CLEARED HIM TO HAVE EARMOLD IMPRESSION TAKEN AND RESUME THE USE OF THE DEVICE. THIS IS THE FINAL REPORT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 14218914 ↗

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Sources and updates

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