Baha 92130Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09321502019552), received between Dec 14, 2017 and Jul 1, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 19641252 ↗
• InjuryJul 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Skin Infection

  MAUDE report 19641251 ↗
• InjuryApr 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE (DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Impaired Healing

  MAUDE report 19009810 ↗
• InjuryApr 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY TO REMOVE THE EXCESS SKIN UNDER GENERAL ANESTHESIA (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing

  MAUDE report 16705416 ↗
• InjuryApr 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY TO REMOVE THE EXCESS SKIN UNDER GENERAL ANESTHESIA (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing

  MAUDE report 16705415 ↗
• InjuryJan 22, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S ABUTMENT WAS REMOVED DUE TO REPEATED INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 9619420 ↗
• InjuryJan 22, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S ABUTMENT WAS REMOVED DUE TO REPEATED INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 9619402 ↗
• InjuryApr 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY UNDERWENT SKIN REVISION (DATE NOT REPORTED). THERE ARE PLANS TO PLACE A LONGER ABUTMENT; HOWEVER YET TO OCCUR AS OF THE DATE OF THIS REPORT.

  Patient problems: Host-Tissue Reaction

  MAUDE report 7391299 ↗
• InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN OVERGROWTH AT THE ABUTMENT SITE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NOT MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Bacterial Infection

  MAUDE report 7119479 ↗