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 ↗
Other Hearing aid, bone conduction devices
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- Baha 92128Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction77 reports
- Baha 92127Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction55 reports
- Baha 90434Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction54 reports
- Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017Cochlear Limited · Hearing aid, bone conduction1 recall0 reports
- Baha 92346Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction49 reports
- Baha 92126Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction27 reports
- Baha 92133Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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