BIA310 Implant 4 mm with 14mm abutment P1340893Recalls & 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 09321502043908), received between Nov 20, 2024 and Nov 20, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Skin Infection1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT INITIALLY EXPERIENCED SOFT TISSUE PROBLEMS CAUSING PERSISTENT LOCALIZED INFLAMMATION AROUND THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED ON (B)(6) 2024, TO ALLOW THE SKIN TO HEAL. HOWEVER, ON (B)(6) 2024, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA IN ORDER TO EXPLANT THE INTERNAL FIXTURE DUE TO AN INFECTION AT THE IMPLANT SITE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Skin Infection; Skin Inflammation/ Irritation
MAUDE report 20731166 ↗
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- Baha 93330Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted269 reports
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- Ponto M52169Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted124 reports
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- 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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