Baha 93336Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BA400 Abutment 12mm · Class 2 · Implant
Quick summary
This Baha abutment is the external connector of an implanted bone conduction hearing aid. Most of the 50 reports describe infection at the abutment site, pain, drainage, slow healing, and skin growing over the abutment, sometimes leading to removal or replacement surgery. No deaths were reported; all 50 reports describe injuries. No recalls name this device, and reporting held steady at 2 reports in each of the last two 12-month periods.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 09321502022767), received between Oct 8, 2017 and Jul 27, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (19 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 Available23
- Patient Device Interaction Problem19
- Adverse Event Without Identified Device or Use Problem9
- Loss of Osseointegration1
Patient problems
- Unspecified Infection16
- Impaired Healing11
- Skin Infection10
- Patient Problem/Medical Problem5
- Bacterial Infection4
- Pain4
- Head Injury3
- Discomfort2
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Patient Device Interaction Problem
Per the clinic, the patient reportedly sustained a head trauma, resulting in inward displacement of the abutment and implant fixture. The patient subsequently experienced pain and swelling at the abutment site, along with skin overgrowth around the abutment. On (b)(6) 2026, the patient underwent a procedure under local anesthesia during which the abutment was removed and the epithelium overlying the implant was debrided. There are plans to convert the patient to a transcutaneous Osia Implant System following complete healing; but had not taken place at the time of this report. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Head Injury; Implant Pain; Swelling/ Edema
MAUDE report 50024224 ↗InjuryNov 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SEVERE SUBJECTIVE PAIN, DISCOMFORT, INTERMITTENT DRAINAGE AND AN INFECTION AROUND THE ABUTMENT. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED ON (B)(6) 2025. THE INTERNAL FIXTURE REMAINS.
Patient problems: Discomfort; Fluid Discharge; Pain; Skin Infection
MAUDE report 23629814 ↗InjuryNov 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SEVERE SUBJECTIVE PAIN, DISCOMFORT, INTERMITTENT DRAINAGE AND AN INFECTION AROUND THE ABUTMENT. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED ON (B)(6) 2025. THE INTERNAL FIXTURE REMAINS.
Patient problems: Discomfort; Fluid Discharge; Pain; Skin Infection
MAUDE report 23629813 ↗InjuryFeb 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN ABUTMENT LOSS AND INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR FOURTEEN DAYS (SPECIFIC DATE NOT REPORTED) AND TOPICAL ANTIBIOTICS TWICE A DAY (SPECIFIC DATE AND DURATION NOT REPORTED). THE ABUTMENT WAS REPLACED ON (B)(6) 2024. THE INTERNAL FIXTURE REMAINS.
Patient problems: Skin Infection
MAUDE report 21371530 ↗InjuryFeb 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN ABUTMENT LOSS AND INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR FOURTEEN DAYS (SPECIFIC DATE NOT REPORTED) AND TOPICAL ANTIBIOTICS TWICE A DAY (SPECIFIC DATE AND DURATION NOT REPORTED). THE ABUTMENT WAS REPLACED ON (B)(6) 2024. THE INTERNAL FIXTURE REMAINS.
Patient problems: Skin Infection
MAUDE report 21371529 ↗InjuryOct 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO UNDERGO A REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2024. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND LONGER ABUTMENT WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 20554785 ↗InjuryOct 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO UNDERGO A REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2024. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND LONGER ABUTMENT WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 20554783 ↗InjuryAug 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE 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 19968756 ↗InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 19631077 ↗InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 19631076 ↗InjuryJun 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY (DEBRIDEMENT) (SPECIFIC DATE NOT REPORTED) DUE TO SKIN OVERGROWTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 19565166 ↗InjuryJun 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY (DEBRIDEMENT) (SPECIFIC DATE NOT REPORTED) DUE TO SKIN OVERGROWTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 19565153 ↗InjuryJun 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY (DEBRIDEMENT) (SPECIFIC DATE NOT REPORTED) DUE TO SKIN OVERGROWTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 19564797 ↗InjuryJun 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY (DEBRIDEMENT) (SPECIFIC DATE NOT REPORTED) DUE TO SKIN OVERGROWTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 19564796 ↗InjuryApr 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED 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: Skin Infection
MAUDE report 19161083 ↗InjuryNov 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH IV ANTIBIOTIC. THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHETIC ON (B)(6) 2023.
Patient problems: Skin Infection
MAUDE report 18202934 ↗InjuryNov 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH IV ANTIBIOTIC. THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHETIC ON (B)(6) 2023.
Patient problems: Skin Infection
MAUDE report 18202933 ↗InjuryDec 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND WAS TREATED WITH A COMBINATION OF STEROID AND ANTIBIOTIC OINTMENT (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT WAS ALSO PRESCRIBED WITH ORAL ANTIBIOTICS FOR TWO WEEKS (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 15994522 ↗InjuryDec 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022 IN ORDER TO REMOVE GRANULATION TISSUE. SUBSEQUENTLY, THE PATIENT WAS ALSO TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15976290 ↗InjuryOct 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6), 2022. THE ABUTMENT WAS EXCHANGED DURING THE SAME SURGERY.
Patient problems: Impaired Healing
MAUDE report 15534730 ↗InjuryOct 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6), 2022. THE ABUTMENT WAS EXCHANGED DURING THE SAME SURGERY.
Patient problems: Impaired Healing
MAUDE report 15534729 ↗InjuryJun 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022. THE ABUTMENT WAS REMOVED DURING THE SAME SURGERY. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTIC FOR 5 DAYS (SPECIFIC DATE NOT REPORTED) AND TOPICAL ANTIBIOTIC (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Unspecified Infection
MAUDE report 14839076 ↗InjuryApr 14, 2022Appropriate 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) 2022 TO REPLACE THE ABUTMENT.
Patient problems: Pain
MAUDE report 14110051 ↗InjuryApr 14, 2022Appropriate 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) 2022 TO REPLACE THE ABUTMENT.
Patient problems: Pain
MAUDE report 14110050 ↗InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 TO REDUCE THE SKIN FLAP COVERING THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 12630123 ↗
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.