Baha 92127Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BIA300 implant 4mm w abutment 6mm · Class 2 · Implant
Quick summary
This Cochlear Baha bone conduction hearing implant is a small implant with an external abutment that sits through the skin behind the ear. The reports mostly describe infection at the implant site, skin overgrowth or problems around the abutment, and the implant losing its grip on the bone so it comes loose. Across 53 reports there are 53 injuries and no deaths, and several patients needed revision surgery or had the implant removed. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 09321502019521), received between Sep 25, 2017 and Sep 15, 2026 — classified as 55 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (14 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
- Loss of Osseointegration14
- Patient Device Interaction Problem12
- Adverse Event Without Identified Device or Use Problem6
- Expulsion2
Patient problems
- Unspecified Infection12
- Host-Tissue Reaction9
- Skin Infection8
- Patient Problem/Medical Problem7
- Bacterial Infection6
- Inadequate Osseointegration6
- No Code Available5
- Impaired Healing3
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration; Expulsion
Per the clinic, the patient experienced partial implant extrusion following head trauma from a pillow, with subsequent infection and loss of osseointegration resulting in fixture loss. The patient was reimplanted with another device on (b)(6), 2026. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 50774540 ↗InjurySep 15, 2026Loss of Osseointegration; Expulsion
Per the clinic, the patient experienced partial implant extrusion following head trauma from a pillow, with subsequent infection and loss of osseointegration resulting in fixture loss. The patient was reimplanted with another device on (b)(6) 2026. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 50774538 ↗InjuryAug 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) FOR UNSPECIFIC MEDICAL REASONS. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2025.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 22780051 ↗InjuryAug 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON AUGUST 12, 2025 WAS FILED INADVERTENTLY. NO EXPLANTATION HAS OCCURRED. PER THE CLINIC, THE PATIENT EXPERIENCED SKIN MANAGEMENT PROBLEM AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS REIMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 22780050 ↗InjuryAug 11, 2025Patient 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 ON (B)(6) 2025, IN ORDER TO REPLACE THE ABUTMENT AND UNDERWENT A SKIN REVISION SURGERY.
Patient problems: Impaired Healing
MAUDE report 22769065 ↗InjuryApr 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH MULTIPLE COURSES OF ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE PATIENT ALSO UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2025 IN ORDER TO PERFORM SKIN FLAP ADVANCEMENT AND TO IRRIGATE THE INFECTED AREA WITH ANTIBIOTIC SOLUTION. THE DEVICE WAS EXPLANTED DURING THE SAME SURGERY.
Patient problems: Skin Infection
MAUDE report 21879236 ↗InjuryApr 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH MULTIPLE COURSES OF ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE PATIENT ALSO UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2025 IN ORDER TO PERFORM SKIN FLAP ADVANCEMENT AND TO IRRIGATE THE INFECTED AREA WITH ANTIBIOTIC SOLUTION. THE DEVICE WAS EXPLANTED DURING THE SAME SURGERY.
Patient problems: Skin Infection
MAUDE report 21879234 ↗InjuryDec 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT WAS REMOVED ON (B)(6) 2024, DUE TO CHRONIC INFECTION. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 20875421 ↗InjuryDec 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT WAS REMOVED ON (B)(6) 2024, DUE TO CHRONIC INFECTION. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 20875419 ↗InjuryApr 30, 2024Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 19210674 ↗InjuryApr 30, 2024Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 19210652 ↗InjuryOct 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN INFECTION AT THE IMPLANT SITE. THE INFECTION IS NOW RESOLVED.
Patient problems: Skin Infection
MAUDE report 17993158 ↗InjuryOct 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN INFECTION AT THE IMPLANT SITE. THE INFECTION IS NOW RESOLVED.
Patient problems: Skin Infection
MAUDE report 17993151 ↗InjuryMar 30, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE AND A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS TREATED WITH IV AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER THE ISSUE DID NOT RESOLVED. SUBSEQUENTLY, THE IMPLANT FIXTURE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2023.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 16641478 ↗InjuryMar 30, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE AND A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS TREATED WITH IV AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER THE ISSUE DID NOT RESOLVED. SUBSEQUENTLY, THE IMPLANT FIXTURE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2023.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 16641477 ↗InjuryJul 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SOFT TISSUE INFECTION AND WAS TREATED WITH ORAL AND IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY TO REPAIR THE SKIN FLAP (DATE NOT REPORTED); HOWEVER, THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND THE PATIENT WILL BE REIMPLANTED ONCE THE SITE HAS HEALED.
Patient problems: Unspecified Infection
MAUDE report 15037616 ↗InjuryFeb 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. IT WAS REPORTED THAT THE ABUTMENT WAS REMOVED ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. DURING THE PROCEDURE, AN IMPLANT WAS PLACED ON THE INTERNAL FIXTURE.
Patient problems: Impaired Healing
MAUDE report 13615025 ↗InjuryFeb 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. IT WAS REPORTED THAT THE ABUTMENT WAS REMOVED ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. DURING THE PROCEDURE, AN IMPLANT WAS PLACED ON THE INTERNAL FIXTURE.
Patient problems: Impaired Healing
MAUDE report 13615020 ↗InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021, IN ORDER TO HAVE A MAGNET PLACED ON THE INTERNAL FIXTURE, CONVERTING THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM. NO OTHER EVENT OR COMPLICATIONS THAT MAY HAVE CONTRIBUTED TO THE DECISION TO CONVERT THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12187156 ↗InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021, IN ORDER TO HAVE A MAGNET PLACED ON THE INTERNAL FIXTURE, CONVERTING THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM. NO OTHER EVENT OR COMPLICATIONS THAT MAY HAVE CONTRIBUTED TO THE DECISION TO CONVERT THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12187155 ↗InjuryDec 21, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A BONE INFECTION AND LACK OF OSSEOINTEGRATION, RESULTING IN LOSS OF FIXTURE. THE IMPLANT AND ABUTMENT WERE BOTH REMOVED ON (B)(6) 2020. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 11052276 ↗InjuryDec 21, 2020Loss of Osseointegration; Loss of Osseointegration
IT IS NOW REPORTED THAT A TOPICAL ANTIBIOTIC WAS ADMINISTERED.
Patient problems: Unspecified Infection
MAUDE report 11052238 ↗InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A BONE INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 10850660 ↗InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 IN ORDER TO HAVE A MAGNET PLACED ON THE INTERNAL FIXTURE, CONVERTING THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM. NO OTHER EVENT OR COMPLICATIONS THAT MAY HAVE CONTRIBUTED TO THE DECISION TO CONVERT THE PATIENT WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 10849640 ↗InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT WAS PLACED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2020, IN ORDER TO REMOVE THE EXCESS SKIN AND REPLACE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Host-Tissue Reaction
MAUDE report 10486276 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.