Baha 93334Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BA400 Abutment 8mm · Class 2 · Implant
Quick summary
This Baha abutment is the external skin connector of an implanted bone conduction hearing aid. The 61 reports mostly describe problems where the skin around the abutment grows over it or becomes infected, sometimes needing antibiotics or revision surgery to remove or replace it, along with slow healing, tissue reactions and pain. All 61 reports are injuries, with no deaths. No recalls name this device, and reporting activity is similar to the previous 12 months (4 versus 3).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 61
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 09321502022743), received between Aug 31, 2017 and Nov 19, 2025 — classified as 61 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (30 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 Problem30
- Appropriate Device Problem Term/Code Not Available26
- Adverse Event Without Identified Device or Use Problem4
- Biocompatibility2
- Insufficient Device Problem Information1
Patient problems
- Impaired Healing20
- Skin Infection12
- Unspecified Infection12
- Host-Tissue Reaction9
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Bacterial Infection3
- Cellulitis3
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED CUTANEOUS INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS ADMINISTERED WITH ORAL ANTIBIOTICS FOR 6 DAYS (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Infection
MAUDE report 23590726 ↗InjuryNov 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE ABUTMENT AND REVISED THE SKIN WITHIN THE SAME SURGERY. THE INTERNAL FIXTURE REMAINS.
Patient problems: Impaired Healing
MAUDE report 23568193 ↗InjuryNov 9, 2025Appropriate 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 A REVISION SURGERY INVOLVING MINOR TISSUE REMOVAL (SPECIFIC DATE NOT REPORTED), FOLLOWED BY AN ABUTMENT REPLACEMENT PROCEDURE PERFORMED UNDER LOCAL ANESTHESIA. PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT.
Patient problems: Impaired Healing
MAUDE report 23507499 ↗InjuryNov 9, 2025Appropriate 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 A REVISION SURGERY INVOLVING MINOR TISSUE REMOVAL (SPECIFIC DATE NOT REPORTED), FOLLOWED BY AN ABUTMENT REPLACEMENT PROCEDURE PERFORMED UNDER LOCAL ANESTHESIA. PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT.
Patient problems: Impaired Healing
MAUDE report 23507498 ↗InjuryMar 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS IN (B)(6) 2024 (SPECIFIC DATE AND DURATION NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 21695410 ↗InjuryMar 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT SKIN REVISION SURGERY AND WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 21695409 ↗InjuryFeb 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND REPEATED SKIN INFECTION AT THE ABUTMENT SITE.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 21465687 ↗InjuryOct 10, 2024Appropriate 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 LOCAL ANAESTHESIA TO REMOVE THE EXCESS SKIN IN (B)(6) 2024 (SPECIFIC DATE NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 20414999 ↗InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND INFECTION ON THE ABUTMENT AND WAS TREATED WITH ORAL, TOPICAL AND IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO UNDERGO A REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2024 AND A NEW ABUTMENT WAS REPLACED.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 19708181 ↗InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND INFECTION ON THE ABUTMENT AND WAS TREATED WITH ORAL, TOPICAL AND IV ANTIBIOTICS (SPECIFIC DATE AN DDURATION NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO UNDERGO A REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2024 AND A NEW ABUTMENT WAS REPLACED.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 19708178 ↗InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024 TO REMOVE THE ABUTMENT DUE TO DEVELOPMENT OF SCAR TISSUE AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Scar Tissue
MAUDE report 18891768 ↗InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024 TO REMOVE THE ABUTMENT DUE TO DEVELOPMENT OF SCAR TISSUE AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Scar Tissue
MAUDE report 18891767 ↗InjuryMar 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH MULTIPLE TOPICAL TREATMENTS INCLUDING ANTIBIOTIC, STEROID, ANTIFUNGAL (SPECIFIC DATE AND DURATION NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 18883040 ↗InjuryMar 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH MULTIPLE TOPICAL TREATMENTS INCLUDING ANTIBIOTIC, STEROID, ANTIFUNGAL (SPECIFIC DATE AND DURATION NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 18883039 ↗InjuryFeb 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND MULTIPLE INFECTIONS AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBITIOCS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 18765116 ↗InjuryJan 30, 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 UNDER GENERAL ANESTHESIA ON (B)(6) 2023. THE PATIENT ABUTMENT WAS ALSO CHANGED FROM 8MM TO 12MM DURING THE SAME SURGERY.
Patient problems: Impaired Healing
MAUDE report 18611415 ↗InjuryJan 30, 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 UNDER GENERAL ANESTHESIA ON (B)(6) 2023. THE PATIENT ABUTMENT WAS ALSO CHANGED FROM 8MM TO 12MM DURING THE SAME SURGERY.
Patient problems: Impaired Healing
MAUDE report 18611414 ↗InjuryJan 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH OVER THE ABUTMENT SITE AND SUBSEQUENTLY, UNDERWENT A SKIN REVISION SURGERY ON (B)(3) 2023 IN ORDER TO DEBRIDE THE OVERGROWN SKIN.
Patient problems: Impaired Healing
MAUDE report 18423521 ↗InjuryOct 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
CORRECTION: THE CORRECT DATE OF AWARENESS IS OCTOBER 02, 2023 NOT OCTOBER 03, 2023 AS PREVIOUS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18000510 ↗InjuryOct 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023, IN ORDER TO REPLACE THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18000509 ↗InjuryOct 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH, PAIN AND CHRONIC INFLAMMATION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER GENERAL ANAESTHESIA ON (B)(6) 2023, AND THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS.
Patient problems: Impaired Healing; Pain; Skin Inflammation/ Irritation
MAUDE report 17993150 ↗InjuryOct 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH, PAIN AND CHRONIC INFLAMMATION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER GENERAL ANAESTHESIA ON (B)(6), 2023, AND THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS.
Patient problems: Impaired Healing; Pain; Skin Inflammation/ Irritation
MAUDE report 17993149 ↗InjuryOct 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AND SKIN OVERGROWTH AT THE ABUTMENT SITE. THE SURGEON PERFORMED CLEANING AND SKIN REMOVAL ON (B)(6) 2023, AND THE ISSUE RESOLVED.
Patient problems: Impaired Healing; Skin Inflammation/ Irritation
MAUDE report 17902194 ↗InjuryAug 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (CELLULITIS) AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL STEROID (SPECIFIC DATE AND DURATION NOT REPORTED) AND ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Cellulitis
MAUDE report 17592897 ↗InjuryJun 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023, IN ORDER TO REPLACE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17223449 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.