BIA310 Implant 4mm with 10mm abutment P1340890Recalls & reported problems
Cochlear Bone Anchored Solutions AB · N/A · Class 2 · Implant
Data updated Oct 18, 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 09321502043922), received between Jun 26, 2019 and Jun 26, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Loss of Osseointegration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2019Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 8737812 ↗
Other Hearing aid, bone conduction, implanted devices
- Baha 93331Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted446 reports
- Baha 93332Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted376 reports
- Baha 93550Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted371 reports
- Baha 93330Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted269 reports
- Baha 93338Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted128 reports
- Ponto M52169Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted124 reports
- Ponto M52170Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted120 reports
- Baha 93335Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted81 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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