Baha 92131Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BA300 abutment 9mm · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09321502019569), received between Sep 15, 2022 and Feb 13, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available6
- Patient Device Interaction Problem5
Patient problems
- Unspecified Infection5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Drug Resistant Bacterial Infection2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT HAD THICK SKIN FLAP AND DEVELOPED AN INFECTION AROUND THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH AN ORAL ANTIBIOTICS, HOWEVER, THE ISSUE DID NOT RESOLVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 24330222 ↗InjuryNov 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHESIA BACK IN 2018 (SPECIFIC DATE NOT REPORTED) BECAUSE PATIENT WAS A NON-USER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23669169 ↗InjuryNov 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHESIA BACK IN 2018 (SPECIFIC DATE NOT REPORTED) BECAUSE PATIENT WAS A NON-USER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23669166 ↗InjuryDec 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT MRSA INFECTIONS AT THE ABUTMENT SITE AND WAS TREATED WITH TOPICAL ANTIBIOTICS. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED ON (B)(6) 2024.
Patient problems: Drug Resistant Bacterial Infection
MAUDE report 20815720 ↗InjuryDec 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT MRSA INFECTIONS AT THE ABUTMENT SITE AND WAS TREATED WITH TOPICAL ANTIBIOTICS. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED ON (B)(6) 2024.
Patient problems: Drug Resistant Bacterial Infection
MAUDE report 20815719 ↗InjuryDec 16, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 15994623 ↗InjuryDec 16, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 15994622 ↗InjurySep 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 15425166 ↗InjurySep 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 15425164 ↗
Other Hearing aid, bone conduction devices
- Baha 92129Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction127 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.