Baha 93357Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 09321502033435), received between Feb 17, 2019 and Sep 1, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Appropriate Device Problem Term/Code Not Available

  Per the clinic, the patient experienced a skin overgrowth on the abutment. The patient underwent revision surgery on (b)(6) 2026, in order to convert the patient to a transcutaneous Osia Implant System. During the procedure, the surrounding granulation tissue was excised under general anesthesia, the Baha abutment was removed, and an Osia implant was placed on the existing internal fixture.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50537559 ↗
• InjuryMar 18, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE ABUTMENT WAS REMOVED ON (B)(6) 2026 UNDER LOCAL ANESTHESIA. THE INTERNAL FIXTURE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 24628840 ↗
• InjuryJan 26, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED LOSS OF OSSEOINTEGRATION AND AN INFECTION AT THE INCISION SITE, WHICH WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATES AND DURATION NOT REPORTED).

  Patient problems: Unspecified Infection

  MAUDE report 24186070 ↗
• InjuryNov 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED GRANULATION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH TOPICAL STEROID AND ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23566106 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA (DATE NOT REPORTED) IN ORDER TO REMOVE THE OVERLYING SKIN TO FULLY EXPOSE THE ABUTMENT AND REPLACE THE ABUTMENT. HOWEVER, DURING THE PROCEDURE DUE TO THICK SKIN AND THE DEPTH OF THE SITE, FIXATION OF THE NEW ABUTMENT TO THE EXISTING FIXTURE WAS DIFFICULT. BLEEDING FROM THE SKIN FURTHER IMPAIRED THE SURGICAL FIELD. BILATERAL SKIN INCISIONS WERE SUBSEQUENTLY MADE, TO IMPROVE VISUALIZATION, AND THE PROCEDURE WAS CONTINUED UNDER MICROSCOPIC GUIDANCE. THE PATIENT WAS THEN REPLACED WITH A NEW ABUTMENT DURING THE SAME SURGERY SUCCESSFULLY.

  Patient problems: Impaired Healing

  MAUDE report 23307962 ↗
• InjuryAug 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH OVER THE ABUTMENT (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2025, IN ORDER TO RESECT THE SUBCUTANEOUS TISSUE SURROUNDING THE ABUTMENT. THE ABUTMENT REMAINS ATTACHED TO THE INTERNAL FIXTURE.

  Patient problems: Impaired Healing

  MAUDE report 22858309 ↗
• InjuryFeb 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND AN INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED).

  Patient problems: Implant Pain; Skin Infection

  MAUDE report 21373127 ↗
• InjuryFeb 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND AN INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED).

  Patient problems: Implant Pain; Skin Infection

  MAUDE report 21373126 ↗
• InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN MRSA INFECTION AT ABUTMENT SITE AND SUBSEQUENTLY WAS HOSPITALIZED FROM (B)(6) 2024 FOR ADMINISTRATION OF IV ANTIBIOTICS. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 20143039 ↗
• InjuryJul 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON JUNE 26, 2024, IN ORDER TO REMOVE THE ABUTMENT DUE TO POOR SOUND QUALITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19802534 ↗
• InjuryJun 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE ABUTMENT WAS REMOVED UNDER GENERAL ANESTHESIA ON (B)(6) 2024, DUE TO A SKIN OVERGROWTH. DURING THE PROCEDURE, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE EXCESS SKIN.

  Patient problems: Impaired Healing

  MAUDE report 19641155 ↗
• InjuryMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS FOR 10 DAYS (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 18824927 ↗
• InjuryMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS FOR 10 DAYS (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 18824926 ↗
• InjuryMar 20, 2023Appropriate 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) 2023 IN ORDER TO REMOVE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16579968 ↗
• InjuryMar 15, 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, IN ORDER TO REPLACE THE OLD ABUTMENT WITH A LONGER ONE.

  MAUDE report 13768346 ↗
• InjuryMar 15, 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, IN ORDER TO REPLACE THE OLD ABUTMENT WITH A LONGER ONE.

  MAUDE report 13768342 ↗
• InjurySep 7, 2021Appropriate 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) 2021 AND UNDERWENT A SKIN REVISION SURGERY IN ORDER TO REMOVE SKIN AROUND THE ABUTMENT. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ADJACENT TO THE ABUTMENT SITE AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Unspecified Infection

  MAUDE report 12431595 ↗
• InjurySep 7, 2021Appropriate 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) 2021 AND UNDERWENT A SKIN REVISION SURGERY IN ORDER TO REMOVE SKIN AROUND THE ABUTMENT. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ADJACENT TO THE ABUTMENT SITE AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Unspecified Infection

  MAUDE report 12431280 ↗
• InjuryOct 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT HAS NOW BEEN REPORTED THAT THE ABUTMENT WAS REMOVED UNDER A GENERAL ANAESTHETIC.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 10646563 ↗
• InjuryOct 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE SURGEON, THE PATIENT EXPERIENCED SKIN OVERGROWTH THAT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Skin Disorders

  MAUDE report 10646562 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTION AT THE ABUTMENT SITE. THERE ARE PLANS TO EXPLANT THE FIXTURE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, JUNE 30TH, 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10210319 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTION AT THE ABUTMENT SITE. THERE ARE PLANS TO EXPLANT THE FIXTURE AND TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10210296 ↗
• InjuryFeb 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE SURGEON, THE PATIENT UNDERWENT REVISION SURGERY (DATE NOT REPORTED), IN ORDER TO CONVERT THE PATIENT TO A PERCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE INTERNAL MAGNET WAS REMOVED AND AN ABUTMENT WAS PLACED ON THE INTERNAL FIXTURE.

  Patient problems: No Code Available

  MAUDE report 8346597 ↗