Baha 90434Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Flange fixture ST 4mm w. BAHA abutment · Class 2 · Implant
All models of Baha (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Cochlear BAHA bone conduction hearing implant, a small fixture and external abutment surgically placed behind the ear to bypass the outer and middle ear. The 54 reports describe ongoing problems with the implant fusing poorly or not at all with the skull, plus infections, pain and skin irritation at the abutment site, sometimes ending with the device being surgically removed. No deaths were reported, and all 54 reports involved injuries.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 09321502014359), received between Aug 2, 2017 and May 13, 2026 — classified as 54 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available26
- Loss of Osseointegration17
- Patient Device Interaction Problem10
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Inadequate Osseointegration10
- Patient Problem/Medical Problem8
- Unspecified Infection8
- Host-Tissue Reaction7
- No Code Available7
- Pain7
- Skin Infection6
- Skin Inflammation/ Irritation3
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT IS PRONE TO ACCIDENTALLY IMPACTING THE ABUTMENT SITE, RESULTING IN THE FORMATION OF BLOOD BLISTERS THAT SUBSEQUENTLY BLEED. THE PATIENT LATER DEVELOPED AN INFECTION AT THE ABUTMENT SITE, NECESSITATING REMOVAL OF THE ABUTMENT ON (B)(6) 2026, UNDER GENERAL ANAESTHESIA.
Patient problems: Blister; Unspecified Infection
MAUDE report 25157497 ↗InjuryMay 13, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT IS PRONE TO ACCIDENTALLY IMPACTING THE ABUTMENT SITE, RESULTING IN THE FORMATION OF BLOOD BLISTERS THAT SUBSEQUENTLY BLEED. THE PATIENT LATER DEVELOPED AN INFECTION AT THE ABUTMENT SITE, NECESSITATING REMOVAL OF THE ABUTMENT ON (B)(6) 2026, UNDER GENERAL ANAESTHESIA.
Patient problems: Blister; Unspecified Infection
MAUDE report 25157496 ↗InjuryMay 8, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFLAMMATION AND INFECTION AT THE IMPLANT SITE (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2026 AND THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection; Skin Inflammation/ Irritation
MAUDE report 25120798 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THIS PATIENT IS A NON-USER. SUBSEQUENTLY, THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200950 ↗InjuryMar 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024, IN ORDER TO REMOVE THE IMPLANT DUE TO REPORTS OF PAIN. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Pain
MAUDE report 18957557 ↗InjuryJan 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AROUND THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL STEROIDS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THIS DID NOT ALLEVIATE THE PROBLEM RESULTING IN A DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2023 AND THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 18432990 ↗InjurySep 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE. TREATMENT FOR THE INFECTION IS UNKNOWN. THE IMPLANT REMAINS IN-SITU.
Patient problems: Skin Infection
MAUDE report 17696298 ↗InjuryJul 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AROUND THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 17331201 ↗InjuryFeb 26, 2023Loss of Osseointegration; Patient Device Interaction Problem; Loss of Osseointegration; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND LOSS OF OSSEOINTEGRATION OF THE IMPLANT ON (B)(6) 2023. THERE ARE PLANS TO RE-IMPLANT THE PATIENT.
Patient problems: Impaired Healing; Inadequate Osseointegration; Pain; Skin Inflammation/ Irritation
MAUDE report 16441323 ↗InjuryJan 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SOFT TISSUE IRRITATION AROUND THE ABUTMENT SITE (DATE NOT REPORTED). SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16135718 ↗InjuryJan 6, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND DRAINAGE AROUND IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS FOR TWO WEEKS (SPECIFIC DATE NOT REPORTED). IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT ALSO EXPERIENCED AN INFECTION AT THE IMPLANT SITE RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Pain; Purulent Discharge; Skin Infection
MAUDE report 16110692 ↗InjuryJan 6, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND DRAINAGE AROUND IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS FOR TWO WEEKS (SPECIFIC DATE NOT REPORTED). IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT ALSO EXPERIENCED AN INFECTION AT THE IMPLANT SITE RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Pain; Purulent Discharge; Skin Infection
MAUDE report 16110691 ↗InjuryMar 9, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AROUND THE ABUTMENT SITE AND WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2022, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Unspecified Infection
MAUDE report 13705702 ↗InjuryDec 29, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS ON (B)(6) 2021. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT
Patient problems: Inadequate Osseointegration
MAUDE report 13104601 ↗InjuryDec 29, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS ON (B)(6) 2021. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT
Patient problems: Inadequate Osseointegration
MAUDE report 13104600 ↗InjuryDec 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2021 DUE TO THE PATIENT BEING A NON-USER. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13040918 ↗InjuryAug 20, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN FIXTURE LOSS. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 12346611 ↗InjuryAug 19, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (DATE NOT REPORTED). THERE ARE NO PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 12340650 ↗InjuryAug 19, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (DATE NOT REPORTED). THERE ARE NO PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 12340649 ↗InjuryJun 10, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 11980402 ↗InjuryJun 10, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 11980398 ↗InjuryOct 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2020, IN ORDER TO REMOVE THE OVERGROWN TISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10632542 ↗InjuryOct 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2020, IN ORDER TO REMOVE THE OVERGROWN TISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10632540 ↗InjurySep 8, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE SURGEON, THE PATIENT EXPERIENCED SKIN GRANULATION AROUND THE ABUTMENT AND PAIN WHICH WAS TREATED WITH A SKIN REVISION AND THE ADMINISTRATION OF ANTIBIOTICS (TYPE OF ADMINISTRATION UNKNOWN). THE ABUTMENT WAS REPLACED WITH A LONGER ABUTMENT ON (B)(6) 2020.
Patient problems: No Code Available; Pain
MAUDE report 10500438 ↗InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE THAT WAS SUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS. THE ABUTMENT WAS REPLACED UNDER A GENERAL ANAESTHETIC ON AN UNKNOWN DATE.
Patient problems: Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 10222570 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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