Baha 92133Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 09321502018968), received between Oct 10, 2017 and Apr 4, 2024 — classified as 21 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 19039209 ↗
• InjuryMay 12, 2023Patient 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 AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Skin Infection

  MAUDE report 16917405 ↗
• InjuryMay 12, 2023Patient 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 AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Skin Infection

  MAUDE report 16917404 ↗
• InjuryDec 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A WOUND INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY WAS TREATED WITH IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Post Operative Wound Infection

  MAUDE report 15930756 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE ABUTMENT SITE AND WAS PLACED ON A 10 DAY COURSE OF ANTIBIOTICS (TYPE NOT REPORTED) ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 11964031 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE ABUTMENT SITE AND WAS PLACED ON A 10 DAY COURSE OF ANTIBIOTICS (TYPE NOT REPORTED) ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 11964030 ↗
• InjuryApr 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT.

  Patient problems: Skin Disorders

  MAUDE report 11705171 ↗
• InjuryApr 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT.

  Patient problems: Skin Disorders

  MAUDE report 11705170 ↗
• InjuryMar 15, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT WHILE WASHING HER HAIR. THERE ARE PLANS TO RE-IMPLANT THE PATIENT (DATE UNKNOWN).

  Patient problems: Insufficient Information

  MAUDE report 11479091 ↗
• InjuryDec 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT SKIN OVERGROWTH ISSUES AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND A MAGNET PLACED ON THE INTERNAL FIXTURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9470960 ↗
• InjuryDec 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT SKIN OVERGROWTH ISSUES AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND A MAGNET PLACED ON THE INTERNAL FIXTURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9470959 ↗
• InjuryNov 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT WAS EXPERIENCING SKIN INFLAMMATION AND PAIN AT THE ABUTMENT SITE. THE PATIENT HAD A CONNECT TO ATTRACT CONVERSION ON AN UNKNOWN DATE.

  Patient problems: No Code Available; Pain; Skin Inflammation

  MAUDE report 9339332 ↗
• InjuryNov 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AND PAIN AT THE ABUTMENT SITE AND WAS ADMINISTERED A TOPICAL OINTMENT OF UNKNOWN TYPE.

  Patient problems: No Code Available; Pain; Skin Inflammation

  MAUDE report 9339329 ↗
• InjuryApr 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE REPORTER, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, THIS HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8525555 ↗
• InjuryFeb 6, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT UNDERWENT AN ABUTMENT CHANGE PROCEDURE ON (B)(6) 2018 UNDER GENERAL ANAESTHESIA.

  Patient problems: No Code Available

  MAUDE report 8313678 ↗
• InjuryOct 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE SURGEON, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. THERE ARE PLANS TO CONVERT THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM; HOWEVER IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 7954955 ↗
• InjuryAug 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DID NOT EXPERIENCE CLINICAL BENEFIT WITH DEVICE USE AND SUBSEQUENTLY THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2018. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 7831290 ↗
• InjuryMay 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY THE ABUTMENT WAS REMOVED AND A LONGER ABUTMENT WAS PLACED ON (B)(6) 2018. DURING THE PROCEDURE A SKIN REVISION WAS PERFORMED WITH THE ADMINISTRATION OF IV ANTIBIOTICS AND THE USE OF MILD IV SEDATION. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS FOR A WEEK.

  Patient problems: Host-Tissue Reaction

  MAUDE report 7505281 ↗
• InjuryMay 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY THE ABUTMENT WAS REMOVED AND A LONGER ABUTMENT WAS PLACED ON (B)(6) 2018. DURING THE PROCEDURE A SKIN REVISION WAS PERFORMED WITH THE ADMINISTRATION OF IV ANTIBIOTICS AND THE USE OF MILD IV SEDATION. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS FOR A WEEK.

  Patient problems: Host-Tissue Reaction

  MAUDE report 7505277 ↗
• InjuryNov 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF ABUTMENT ON (B)(6) 2017, AND WAS SUBSEQUENTLY TAKEN TO THE OR TO PLACE A NEW ABUTMENT. DURING THE PROCEDURE, GRANULATED TISSUE WAS NOTED OVER THE IMPLANT, AND WAS SUBSEQUENTLY EXCISED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7007915 ↗
• InjuryOct 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A RECURRENT WOUND WITH BLISTERING, SWELLING AND ULCERATION AT THE IMPLANT SITE FOR A DURATION OF 3 YEARS. THE FIRST OCCURRENCE BEGAN IN 2014, AND THE PATIENT REPORTEDLY UNDERWENT REVISION SURGERY IN (B)(6) 2014, IN ORDER TO EXCISE EXCESS SKIN AT THE ABUTMENT AND CLEAN THE WOUND. DUE TO THE ONGOING HEALING ISSUES, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2017, IN ORDER TO EXCISE ADDITIONAL SKIN OVERGROWTH AT THE ABUTMENT SITE. THE ABUTMENT WAS REMOVED; HOWEVER, THE IMPLANTED FIXTURE REMAINS INSITU.

  Patient problems: Hearing Impairment; Host-Tissue Reaction

  MAUDE report 6939402 ↗