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Baha 90432Recalls & reported problems

Cochlear Bone Anchored Solutions AB · Flange fixture ST 4mm · Class 2 · Implant

All models of Baha (29)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09321502012904), received between Feb 3, 2019 and Mar 22, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 reports).

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

  • Loss of Osseointegration3

Patient problems

  • Head Injury1
  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 22, 2021Loss of Osseointegration; Loss of Osseointegration

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. AN INFECTION WAS ALSO PRESENT, WITH THE PATIENT BEING TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

    Patient problems: Unspecified Infection

    MAUDE report 11548292 ↗
  • InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2020.

    Patient problems: Head Injury

    MAUDE report 10300011 ↗
  • InjuryFeb 3, 2019Loss of Osseointegration; Loss of Osseointegration

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS ON (B)(6) 2019. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER HAS YET TO OCCUR AS OF THE DATE OF THIS REPORT.

    Patient problems: No Code Available

    MAUDE report 8300616 ↗

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Sources and updates

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