Baha 93335Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BA400 Abutment 10mm · Class 2 · Implant
Quick summary
This Cochlear Baha abutment is an implanted bone-conduction hearing aid component. Reports mostly describe skin problems at the abutment site—skin overgrowth, infections, inflammation, and impaired healing—sometimes needing revision surgery under anesthesia. There are 81 adverse event reports that name its identifier, with 81 injuries and no deaths. No recalls name this device. Reports dropped from 12 to 2 in the most recent 12 months.
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
- 81
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 09321502022750), received between Aug 3, 2017 and May 19, 2026 — classified as 81 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (35 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 Available36
- Patient Device Interaction Problem35
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information2
- No Apparent Adverse Event2
- Therapeutic or Diagnostic Output Failure2
- Failure to Osseointegrate1
- Loss of Osseointegration1
Patient problems
- Unspecified Infection22
- Impaired Healing18
- Host-Tissue Reaction13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Bacterial Infection6
- No Clinical Signs, Symptoms or Conditions6
- Skin Infection6
- Skin Inflammation/ Irritation6
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ABUTMENT REPLACEMENT PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2026. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25212254 ↗InjuryMay 19, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ABUTMENT REPLACEMENT PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2026. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25212253 ↗InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED REPEATED SKIN INFECTIONS AT THE ABUTMENT SITE (DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE ON (B)(6) 2025. DURING THE SAME PROCEDURE, THE PATIENT WAS RE-IMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM UNDER GENERAL ANESTHESIA AT THE NEW IMPLANT SITE.
Patient problems: Skin Infection
MAUDE report 23080897 ↗InjurySep 12, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE ABUTMENT PRIOR TO CONVERSION OF BAHA TO COCHLEAR IMPLANT DUE TO PROGRESSIVE HEARING LOSS. THE CONVERSION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23037530 ↗InjurySep 10, 2025Patient 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) 2016.
Patient problems: Impaired Healing
MAUDE report 23016641 ↗InjurySep 10, 2025Patient 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) 2016.
Patient problems: Impaired Healing
MAUDE report 23016640 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT UNDERWENT ABUTMENT REMOVAL UNDER GENERAL ANESTHESIA ON (B)(6) 2025, TO UPGRADE TO NEWER TECHNOLOGY IN THE FUTURE. ADDITIONALLY, WOUND DEBRIDEMENT WAS CARRIED OUT DURING THE PROCEDURE TO AID HEALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476500 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT UNDERWENT ABUTMENT REMOVAL UNDER GENERAL ANESTHESIA ON (B)(6) 2025, TO UPGRADE TO NEWER TECHNOLOGY IN THE FUTURE. ADDITIONALLY, WOUND DEBRIDEMENT WAS CARRIED OUT DURING THE PROCEDURE TO AID HEALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476495 ↗InjuryApr 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE AND UNDERWENT AN ABUTMENT REMOVAL PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2024.
Patient problems: Impaired Healing
MAUDE report 21932218 ↗InjuryApr 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE AND UNDERWENT AN ABUTMENT REMOVAL PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2024.
Patient problems: Impaired Healing
MAUDE report 21932217 ↗InjuryJan 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 21088796 ↗InjuryJan 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 21088795 ↗InjuryNov 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT ABUTMENT WAS CHANGED UNDER GENERAL ANESTHESIA ON AUGUST 20, 2024 DUE TO PREVIOUS ABUTMENT SPONTANEOUSLY FELL OUT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20720669 ↗InjuryNov 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT ABUTMENT WAS CHANGED UNDER GENERAL ANESTHESIA ON AUGUST 20, 2024 DUE TO PREVIOUS ABUTMENT SPONTANEOUSLY FELL OUT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20720428 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT WAS ELECTIVELY REMOVED UNDER GENERAL ANESTHESIA ON (B)(6) 2024. THE IMPLANTED DEVICE REMAINS.
Patient problems: Fibrosis; No Clinical Signs, Symptoms or Conditions; Scar Tissue
MAUDE report 20554439 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT WAS ELECTIVELY REMOVED UNDER GENERAL ANESTHESIA ON (B)(6) 2024. THE IMPLANTED DEVICE REMAINS.
Patient problems: Fibrosis; No Clinical Signs, Symptoms or Conditions; Scar Tissue
MAUDE report 20554423 ↗InjuryAug 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL ANTIBIOTICS FOR 2 WEEKS (SPECIFIC DATE NOT REPORTED). THE PATIENT ALSO WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024, IN ORDER TO REPLACE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Infection
MAUDE report 19915655 ↗InjuryAug 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Infection
MAUDE report 19914943 ↗InjuryJan 31, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023, FOR AN ATTEMPT OF ABUTMENT REMOVAL; HOWEVER, THE ABUTMENT COULD NOT BE REMOVED. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18611578 ↗InjuryJan 31, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023, FOR AN ATTEMPT OF ABUTMENT REMOVAL; HOWEVER, THE ABUTMENT COULD NOT BE REMOVED. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18611577 ↗InjuryDec 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) DUE TO PAIN, SKIN OVERGROWTH AND DRAINAGE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT. THE PATIENT ALSO UNDERWENT REVISION SURGERY TO SUTURE AND DEBRIDE THE WOUND DURING THE SAME SURGERY. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing; Pain
MAUDE report 18253919 ↗InjuryDec 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) DUE TO PAIN, SKIN OVERGROWTH AND DRAINAGE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT. THE PATIENT ALSO UNDERWENT REVISION SURGERY TO SUTURE AND DEBRIDE THE WOUND DURING THE SAME SURGERY. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing; Pain
MAUDE report 18253918 ↗InjuryJul 14, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 IN ORDER TO REMOVE THE ABUTMENT DUE TO POOR PERFORMANCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17323432 ↗InjuryJun 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND INFLAMMATION ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing; Skin Inflammation/ Irritation
MAUDE report 17168677 ↗InjuryJun 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND INFLAMMATION ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing; Skin Inflammation/ Irritation
MAUDE report 17168676 ↗
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 93334Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted61 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.