Baha 92128Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BI300 implant 3mm · Class 2 · Implant
Quick summary
This Cochlear Baha bone-conduction implant has 77 adverse event reports, with no deaths and 77 injuries. Reports mostly describe the implant failing to integrate with bone, sometimes requiring removal, along with infections. No recalls name this device. Reports rose from 1 to 5 in the last 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
- 77
- Deaths reported
- 0
- Injuries reported
- 77
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 09321502019538), received between Jul 30, 2017 and Apr 20, 2026 — classified as 77 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (29 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
- Loss of Osseointegration29
- Appropriate Device Problem Term/Code Not Available26
- Adverse Event Without Identified Device or Use Problem9
- Patient Device Interaction Problem9
- Loosening of Implant Not Related to Bone-Ingrowth4
- Failure to Osseointegrate1
Patient problems
- Inadequate Osseointegration14
- Patient Problem/Medical Problem11
- No Code Available10
- Unspecified Infection9
- No Clinical Signs, Symptoms or Conditions7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Head Injury5
- Host-Tissue Reaction4
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 24921446 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6), 2026 DUE TO THE NEEDING OF MRI PROCEDURES. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777045 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2026 DUE TO THE NEEDING OF MRI PROCEDURES. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777044 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2026; DUE TO THE NEED OF MRI PROCEDURES. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772880 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2026, DUE TO THE NEED OF MRI PROCEDURES. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772879 ↗InjuryJan 2, 2025Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED BLEEDING, INFECTION AND A LOSS OF OSSEOINTEGRATION WITH THE DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21064119 ↗InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 DUE TO FEEDBACK AND RETENTION ISSUES. THE PATIENT WAS REIMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20143291 ↗InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024 DUE TO FEEDBACK AND RETENTION ISSUES. THE PATIENT WAS REIMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20143268 ↗InjuryJun 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, DURING THE IMPLANTATION SURGERY ON (B)(6) 2024, THE SURGERY TIME WAS EXTENDED FOR 2 HOURS DUE TO UNABLE TO SCREW AN OSIA IMPLANT ON THE INTERNAL FIXTURE. A BACK-UP INTERNAL FIXTURE WAS USED WITH NO FURTHER ISSUES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19517326 ↗InjuryJun 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, DURING THE IMPLANTATION SURGERY ON (B)(6) 2024, THE SURGERY TIME WAS EXTENDED FOR 2 HOURS DUE TO UNABLE TO SCREW AN OSIA IMPLANT ON THE INTERNAL FIXTURE. A BACK-UP INTERNAL FIXTURE WAS USED WITH NO FURTHER ISSUES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19517325 ↗InjuryJun 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE FIXTURE WAS EXPLANTED ON (B)(6) 2024 UNDER GENERAL ANAESTHESIA. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 19490014 ↗InjuryJun 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE FIXTURE WAS EXPLANTED ON (B)(6) 2024 UNDER GENERAL ANAESTHESIA. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 19485885 ↗InjuryApr 22, 2024Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2024.
Patient problems: Inadequate Osseointegration
MAUDE report 19161115 ↗InjuryMar 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF FIXTURE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2024.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 18966662 ↗InjuryMar 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE ABUTMENT ON (B)(6), 2024 UNDER GENERAL ANESTHESIA.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 18966661 ↗InjurySep 13, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 17741839 ↗InjuryJul 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). 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 17296454 ↗InjuryMay 30, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT (REASON UNKNOWN). THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE.
Patient problems: Inadequate Osseointegration
MAUDE report 17017651 ↗InjuryMay 30, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT (REASON UNKNOWN). THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE.
Patient problems: Inadequate Osseointegration
MAUDE report 17017650 ↗InjuryApr 10, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16705949 ↗InjuryApr 10, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16705947 ↗InjuryJan 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT EXPERIENCED ONGOING PAIN AT HER BAHA ATTRACT SITE SINCE HER INITIAL IMPLANTATION AND HAD REQUESTED ITS REMOVAL. THE DEVICE WAS EXPLANTED UNDER A GENERAL ANAESTHETIC.
Patient problems: Discomfort
MAUDE report 16109763 ↗InjuryOct 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND THE DEVICE WAS EXPLANTED ON (B)(6) 2022, DUE TO DAMAGE TO THE ABUTMENT SUBSEQUENT TO A HEAD INJURY. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Head Injury
MAUDE report 15678087 ↗InjurySep 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED DISCOMFORT WITH THE PLACEMENT SITE OF THE IMPLANT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 TO CONVERT THE PATIENT TO A PERCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE INTERNAL MAGNET WAS REMOVED AND AN OSIA WAS PLACED ON THE INTERNAL FIXTURE.
Patient problems: Implant Pain
MAUDE report 12451250 ↗InjurySep 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED DISCOMFORT WITH THE PLACEMENT SITE OF THE IMPLANT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021 TO CONVERT THE PATIENT TO A PERCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE INTERNAL MAGNET WAS REMOVED AND AN OSIA WAS PLACED ON THE INTERNAL FIXTURE.
Patient problems: Implant Pain
MAUDE report 12451246 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.