Baha 93331Recalls & reported problems

Summary

The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 09321502022712), received between May 28, 2017 and Sep 17, 2026 — classified as 446 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (128 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 25 most recent of 446 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Patient Device Interaction Problem

  Per the clinic, the patient experienced pain, irritation, tenderness, drainage and an infection at the abutment site. Subsequently, the patient was treated with oral antibiotic (specific date and duration not reported) and the abutment was removed on (b)(6) 2026. During the removal, the skin at the abutment site was erythematous and edematous, and the patient was treated with topical antibiotic. There are plans to place a new abutment; however, this has not occurred as of the date of this report.

  Patient problems: Erythema; Fluid Discharge; Pain; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 50799387 ↗
• InjurySep 17, 2026Patient Device Interaction Problem

  Per the clinic, the patient experienced pain, irritation, tenderness, drainage and an infection at the abutment site. Subsequently, the patient was treated with oral antibiotic (specific date and duration not reported) and the abutment was removed on (b)(6) 2026. During the removal, the skin at the abutment site was erythematous and edematous, and the patient was treated with topical antibiotic. There are plans to place a new abutment; however, this has not occurred as of the date of this report.

  Patient problems: Erythema; Fluid Discharge; Pain; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 50799386 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  Per the clinic, the patient experienced skin overgrowth on the abutment. Subsequently, the patient was placed under general anesthesia on (b)(6) 2026, in order to replace the abutment to a much longer length. The internal fixture remains.

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

  MAUDE report 50728336 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  Per the clinic, the patient experienced skin overgrowth on the abutment. Subsequently, the patient was placed under general anaesthesia on (b)(6) 2026, in order to replace the abutment to a much longer length. The internal fixture remains.

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

  MAUDE report 50728334 ↗
• InjurySep 8, 2026Loss of Osseointegration; Detachment of Device or Device Component

  Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss due to trauma. The patient was reimplanted with another cochlear device on (b)(6) 2023.

  Patient problems: Head Injury; Inadequate Osseointegration

  MAUDE report 50668106 ↗
• InjurySep 8, 2026Loss of Osseointegration; Detachment of Device or Device Component

  Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss due to trauma. The patient was reimplanted with another cochlear device on (b)(6) 2023.

  Patient problems: Head Injury; Inadequate Osseointegration

  MAUDE report 50668105 ↗
• InjuryMay 17, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT ABUTMENT SITE AND HISTORY OF DRAINAGE (SPECIFIC SITE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER, THE ISSUE DID NOT RESOLVE. IT WAS ALSO REPORTED THAT THE ABUTMENT WAS REMOVED IN THE CLINIC OFFICE AND THE IMPLANTED DEVICE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 25196888 ↗
• InjuryMay 17, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT ABUTMENT SITE AND HISTORY OF DRAINAGE (SPECIFIC SITE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER, THE ISSUE DID NOT RESOLVE. IT WAS ALSO REPORTED THAT THE ABUTMENT WAS REMOVED IN THE CLINIC OFFICE AND THE IMPLANTED DEVICE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 25196887 ↗
• InjuryMay 4, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED INFECTION, SKIN OVERGROWTH AND GRANULATION TISSUE AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE PATIENT ALSO WAS TREATED WITH STEROID INJECTIONS 4 TIMES (DATE NOT REPORTED). THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2026 UNDER GENERAL ANESTHESIA TO DEBRIDE THE AFFECTED TISSUE WITH SILVER NITRATE CAUTERIZATION. THE DEVICE WAS EXPLANTED DURING THE SAME SURGERY.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 25065381 ↗
• InjuryMay 4, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED INFECTION, SKIN OVERGROWTH AND GRANULATION TISSUE AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE PATIENT ALSO WAS TREATED WITH STEROID INJECTIONS 4 TIMES (DATE NOT REPORTED). THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2026 UNDER GENERAL ANESTHESIA TO DEBRIDE THE AFFECTED TISSUE WITH SILVER NITRATE CAUTERIZATION. THE DEVICE WAS EXPLANTED DURING THE SAME SURGERY.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 25065380 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) FOR THE INFECTION. THE PATIENT SUBSEQUENTLY UNDERWENT AN ABUTMENT REMOVAL ON (B)(6) 2025. THE INTERNAL FIXTURE REMAINS AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON THE CONTRALATERAL SIDE DURING THE SAME SURGERY.

  Patient problems: Skin Infection

  MAUDE report 24907290 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 24907287 ↗
• InjuryMar 30, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24709908 ↗
• InjuryMar 30, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24709815 ↗
• InjuryMar 16, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND INFECTION. SUBSEQUENTLY, THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE ON (B)(6) 2026 AND NEW ABUTMENT WAS PLACED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 24613863 ↗
• InjuryMar 16, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND INFECTION. SUBSEQUENTLY, THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE ON (B)(6) 2026 AND NEW ABUTMENT WAS PLACED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 24613862 ↗
• InjuryMar 15, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE AND ABUTMENT LOSS (SPECIFIC DATE NOT REPORTED). A REVISION SURGERY IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME 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 24602184 ↗
• InjuryMar 15, 2026Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE AND ABUTMENT LOSS (SPECIFIC DATE NOT REPORTED). A REVISION SURGERY IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME 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 24602183 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INTERMITTENT WEEPING IN GRANULATION TISSUE AROUND THE ABUTMENT AND AN INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY THE PATIENT WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). THE PATIENT ALSO UNDERWENT A SKIN REVISION SURGERY (SPECIFIC DATE NOT REPORTED) WHERE AN ELLIPSE OF THE SKIN AROUND THE ABUTMENT WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 24573725 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  CORRECTION (F6 AND F13): THE CORRECT MANUFACTURER DATE OF AWARENESS IS (B)(6) 2026, NOT (B)(6) 2026 AS PREVIOUSLY REPORTED IN INITIAL MDR [6000034-2026-01146]. PER THE CLINIC, THE PATIENT ALSO EXPERIENCED SKIN OVERGROWTH AROUND THE ABUTMENT. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 24566308 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT WAS ALSO TREATED WITH SILVER NITRATE (SPECIFIC DATE AND DURATION NOT REPORTED); HOWEVER, THE ISSUE DID NOT RESOLVE. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 24565902 ↗
• InjuryMar 11, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT WAS ALSO TREATED WITH SILVER NITRATE (SPECIFIC DATE AND DURATION NOT REPORTED); HOWEVER, THE ISSUE DID NOT RESOLVE. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Impaired Healing; Skin Infection

  MAUDE report 24565901 ↗
• InjuryFeb 26, 2026Loss 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 WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. THE PATIENT WAS SUBSEQUENTLY FITTED WITH THE DEVICE ON A SOUNDARC ON (B)(6) 2026.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24451522 ↗
• InjuryFeb 22, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND WAS TREATED WITH ANTIBIOTICS (TYPE NOT REPORTED) ON (B)(6) 2025 FOR A DURATION OF ONE MONTH. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 24410496 ↗
• InjuryFeb 22, 2026Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND WAS TREATED WITH ANTIBIOTICS (TYPE NOT REPORTED) ON (B)(6) 2025 FOR A DURATION OF ONE MONTH. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 24410495 ↗