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Baha 92141Recalls & reported problems

Cochlear Bone Anchored Solutions AB · Widening drill 4 mm with countersink · Class 2

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 09321502019620), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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

  • Patient Device Interaction Problem1

Patient problems

  • Impaired Healing1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJul 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AND SKIN OVERGROWTH AT THE ABUTMENT SITE (DATE NOT REPORTED). THE PATIENT WAS TREATED WITH ORAL AND IV ANTIBIOTICS, HOWEVER THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANAESTHESIA ON (B)(6) 2022. THE IMPLANTED DEVICE REMAINS.

    Patient problems: Impaired Healing; Unspecified Infection

    MAUDE report 15118972 ↗

Other Hearing aid, bone conduction devices

All Hearing aid, bone conduction devices →

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