Baha 93337Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BA400 Abutment 14mm · Class 2 · Implant
Quick summary
This Baha abutment is the external skin-fitting piece of an implanted bone conduction hearing aid. The 35 reports mostly describe skin problems around the abutment — overgrowth and keloid scarring, slow healing, infection, pain and inflammation — and several patients needed revision surgery to trim excess skin or tissue. All 35 reports describe injuries, with no deaths. Reports rose from 2 in the prior 12 months to 8 in the most recent 12 months. No recalls name this device.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 09321502033459), received between Jul 25, 2017 and May 18, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (22 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 Problem22
- Appropriate Device Problem Term/Code Not Available17
- Biocompatibility1
- Loss of Osseointegration1
Patient problems
- Impaired Healing16
- Skin Infection6
- Abnormal scarring4
- Host-Tissue Reaction3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Granuloma2
- Inflammation2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND KELOIDS AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2026, FOR EXCISION OF EXCESS SKIN AND SOFT TISSUE THINNING. THE IMPLANTED DEVICE REMAINS.
Patient problems: Abnormal scarring
MAUDE report 25211896 ↗InjuryMay 18, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND KELOIDS AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2026, FOR EXCISION OF EXCESS SKIN AND SOFT TISSUE THINNING. THE IMPLANTED DEVICE REMAINS.
Patient problems: Abnormal scarring
MAUDE report 25211895 ↗InjuryMay 10, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND KELOIDS AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2026, FOR EXCISION OF EXCESS SKIN AND SOFT TISSUE THINNING. THE IMPLANTED DEVICE REMAINS.
Patient problems: Abnormal scarring
MAUDE report 25133676 ↗InjuryMay 10, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AND KELOIDS AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2026, FOR EXCISION OF EXCESS SKIN AND SOFT TISSUE THINNING. THE IMPLANTED DEVICE REMAINS.
Patient problems: Abnormal scarring
MAUDE report 25133675 ↗InjuryJan 8, 2026Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN ONGOING INFECTION ASSOCIATED WITH THE ABUTMENT.
Patient problems: Insufficient Information; Skin Infection
MAUDE report 24016616 ↗InjuryJan 8, 2026Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT WAS REMOVED WITH FORCE UNDER GENERAL ANESTHESIA ON (B)(6) 2025 DUE TO UNKNOWN REASON. DURING THE SAME PROCEDURE ON (B)(6) 2025, THE PATIENT ALSO UNDERWENT REVISION SURGERY TO EXCISE SURROUNDING TISSUE.
Patient problems: Insufficient Information; Skin Infection
MAUDE report 24016615 ↗InjuryNov 10, 2025Appropriate 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 DEVELOPED SKIN OVERGROWTH, PAIN AND INFLAMMATION AT THE ABUTMENT SITE. THE PATIENT UNDERWENT STEROID INJECTIONS IN (B)(6) 2025 (SPECIFIC DATE NOT REPORTED) AT THE ABUTMENT SITE. THE PATIENT WAS ALSO TREATED WITH TOPICAL STEROIDS AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) TO MANAGE REPORTED ISSUE. IN ADDITION, A SKIN REVISION PROCEDURE (SPECIFIC DATE NOT REPORTED) WAS PERFORMED TO IMPROVE LOCAL TISSUE CONDITION AND ABUTMENT HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Granuloma; Impaired Healing; Inflammation; Pain
MAUDE report 23519347 ↗InjuryNov 10, 2025Appropriate 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 DEVELOPED SKIN OVERGROWTH, PAIN AND INFLAMMATION AT THE ABUTMENT SITE. THE PATIENT UNDERWENT STEROID INJECTIONS IN (B)(6) 2025 (SPECIFIC DATE NOT REPORTED) AT THE ABUTMENT SITE. THE PATIENT WAS ALSO TREATED WITH TOPICAL STEROIDS AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) TO MANAGE REPORTED ISSUE. IN ADDITION, A SKIN REVISION PROCEDURE (SPECIFIC DATE NOT REPORTED) WAS PERFORMED TO IMPROVE LOCAL TISSUE CONDITION AND ABUTMENT HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Granuloma; Impaired Healing; Inflammation; Pain
MAUDE report 23519345 ↗InjuryJun 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AROUND THE ABUTMENT SITE AND WAS TREATED WITH ORAL ANTIBIOTICS IN 2021 (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 22203031 ↗InjuryJun 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AROUND THE ABUTMENT SITE AND WAS TREATED WITH ORAL ANTIBIOTICS IN 2021 (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 22203030 ↗InjuryMar 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 FOR AN ABUTMENT REMOVAL AND SKIN REVISION TO REMOVE EXCESS SKIN AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 18909744 ↗InjuryMar 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 FOR AN ABUTMENT REMOVAL AND SKIN REVISION TO REMOVE EXCESS SKIN AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 18909743 ↗InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE. THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2023, IN ORDER TO REMOVE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 17496178 ↗InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE. THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2023, IN ORDER TO REMOVE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 17496177 ↗InjuryMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6) 2022 TO REMOVE SMALL AMOUNT OF CRUST AROUND THE SURGICAL SITE.
Patient problems: Impaired Healing
MAUDE report 16990381 ↗InjuryMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6) 2022 TO REMOVE SMALL AMOUNT OF CRUST AROUND THE SURGICAL SITE.
Patient problems: Impaired Healing
MAUDE report 16990380 ↗InjuryMay 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED HYPERTROPHIC SCARRING AT THE ABUTMENT SITE (DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6) 2021 AND THE PATIENT WAS TREATED WITH STEROID INJECTION (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 16990061 ↗InjuryMay 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED HYPERTROPHIC SCARRING AT THE ABUTMENT SITE (DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6) 2021 AND THE PATIENT WAS TREATED WITH STEROID INJECTION (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 16990058 ↗InjuryFeb 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND SKIN OVERGROWTH AROUND ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY IN ORDER TO REMOVE THE ABUTMENT UNDER GENERAL ANESTHESIA ON (B)(6) 2023. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 16376645 ↗InjuryFeb 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND SKIN OVERGROWTH AROUND ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY IN ORDER TO REMOVE THE ABUTMENT UNDER GENERAL ANESTHESIA ON (B)(6) 2023. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 16376644 ↗InjuryDec 29, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
CORRECTION: THE PREVIOUS MDR SUBMITTED ON DECEMBER 30, 2022 WAS FILED INADVERTENTLY. FURTHER INFORMATION ON THE INFECTION AND ANTIBIOTICS WERE PROVIDED WITH REPORT NUMBER 6000034-2022-01767.
Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Infection
MAUDE report 16075879 ↗InjuryDec 29, 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 THAT WAS SUCCESSFULLY TREATED WITH ORAL AND TOPICAL ANTIBIOTICS. THE ABUTMENT WAS REMOVED ON (B)(6) 2022. THE IMPLANT REMAINS IN-SITU.
Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Infection
MAUDE report 16075878 ↗InjuryDec 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT WAS TREATED WITH STEROID (SPECIFIC DATE AND DURATION NOT REPORTED) DUE TO OTHER MEDICAL REASONS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15984966 ↗InjuryDec 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT WAS TREATED WITH STEROID (SPECIFIC DATE AND DURATION NOT REPORTED) DUE TO OTHER MEDICAL REASONS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15984965 ↗InjuryOct 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED A HYPERTROPHIC SCAR AT THE ABUTMENT SITE AND WAS TREATED WITH TOPICAL STEROID.
Patient problems: Scar Tissue
MAUDE report 15637300 ↗
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.