Baha 93333Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BA400 Abutment 6mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 09321502022736), received between Mar 18, 2018 and Mar 12, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (10 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
- Patient Device Interaction Problem10
- Appropriate Device Problem Term/Code Not Available5
- Therapeutic or Diagnostic Output Failure2
Patient problems
- Impaired Healing7
- Pain4
- Abnormal scarring2
- Skin Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Host-Tissue Reaction1
- Unspecified Infection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND THE PATIENT SUBSEQUENTLY UNDERWENT A SKIN REVISION SURGERY TO REMOVE HYPERTROPHIC SCAR/KELOID AT THE ABUTMENT SITE ON (B)(6) 2025. THE ABUTMENT WAS ALSO REMOVED DURING THE SAME SURGERY. THE INTERNAL FIXTURE REMAINS.
Patient problems: Abnormal scarring; Pain
MAUDE report 24577101 ↗InjuryMar 12, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND THE PATIENT SUBSEQUENTLY UNDERWENT A SKIN REVISION SURGERY TO REMOVE HYPERTROPHIC SCAR/KELOID AT THE ABUTMENT SITE ON (B)(6) 2025. THE ABUTMENT WAS ALSO REMOVED DURING THE SAME SURGERY. THE INTERNAL FIXTURE REMAINS.
Patient problems: Abnormal scarring; Pain
MAUDE report 24577100 ↗InjuryJan 12, 2026Therapeutic or Diagnostic Output Failure; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025 FOR A PROCEDURE TO REMOVE THE ABUTMENT DUE TO PAIN AND PERFORMANCE DECREMENT. THE INTERNAL FIXTURE REMAINS.
Patient problems: Pain
MAUDE report 24033524 ↗InjuryJan 12, 2026Therapeutic or Diagnostic Output Failure; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025 FOR A PROCEDURE TO REMOVE THE ABUTMENT DUE TO PAIN AND PERFORMANCE DECREMENT. THE INTERNAL FIXTURE REMAINS.
Patient problems: Pain
MAUDE report 24033479 ↗InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2024 UNDER GENERAL ANAESTHESIA. THE PATIENT ALSO DEVELOPED AN INFECTION AT THE IMPLANT SITE WHICH WAS TREATED WITH IV AND ORAL ANTIBIOTICS. THE PATIENT ABUTMENT WAS REPLACED TO 12MM ABUTMENT.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 19969226 ↗InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6), 2024 UNDER GENERAL ANAESTHESIA. THE PATIENT ALSO DEVELOPED AN INFECTION AT THE IMPLANT SITE WHICH WAS TREATED WITH IV AND ORAL ANTIBIOTICS. THE PATIENT ABUTMENT WAS REPLACED TO 12MM ABUTMENT.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 19969218 ↗InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH OVER THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024 IN ORDER TO REPLACE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 18927529 ↗InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH OVER THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024 IN ORDER TO REPLACE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 18927528 ↗InjuryFeb 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED FEEDBACK WITH THE DEVICE AND SUBSEQUENTLY WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REPLACE THE ABUTMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18673562 ↗InjuryMay 9, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6)2022 IN ORDER TO REMOVE THE EXCESS SKIN AND REPLACE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 14332688 ↗InjuryMay 9, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022 IN ORDER TO REMOVE THE EXCESS SKIN AND REPLACE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 14332686 ↗InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND UNDERWENT REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2022.
Patient problems: Impaired Healing
MAUDE report 13468260 ↗InjuryOct 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTION AT THE ABUTMENT SIDE AND WAS TREATED WITH A COMBINATION ANTIBIOTICS AND STEROID TOPICAL OINTMENT (DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2021. THE ABUTMENT IS REMOVED DURING THE SAME SURGERY.
Patient problems: Unspecified Infection
MAUDE report 12622115 ↗InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT SKIN INFECTIONS AT ABUTMENT SITE AND SUBSEQUENTLY UNDERWENT SKIN REVISION SURGERY TO REMOVE ABUTMENT. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.
Patient problems: Bacterial Infection
MAUDE report 10371325 ↗InjuryMar 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE AND SUBSEQUENTLY UNDERWENT SKIN REVISION SURGERY TO DEBRIDE THE AREA ON (B)(6) 2018. THE IMPLANTED DEVICE REMAINS.
Patient problems: Host-Tissue Reaction
MAUDE report 7347956 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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