Baha 90480Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09321502014298), received between Jan 10, 2018 and Sep 1, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  Per the clinic, the device was explanted on (b)(6) 2025; under general anesthesia due to abutment fell out. During the procedure, the patient was converted to transcutaneous Osia Implant System.

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

  MAUDE report 50536368 ↗
• InjuryAug 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Skin Infection

  MAUDE report 17468195 ↗
• InjuryAug 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Skin Infection

  MAUDE report 17468194 ↗
• InjuryJun 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE SURGEON, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY UNDERWENT A SKIN REVISION (DATE NOT REPORTED) TO REPLACE THE ABUTMENT AND CAUTERIZE THE SKIN. IT WAS ALSO REPORTED THAT THE PATIENT WAS ADMINISTERED TOPICAL ANTIBIOTICS (DATE NOT REPORTED).

  Patient problems: Host-Tissue Reaction

  MAUDE report 8661446 ↗
• InjuryMay 3, 2018Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED). THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: No Code Available

  MAUDE report 7485705 ↗
• InjuryApr 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION, SWELLING AND DRAINAGE AT THE IMPLANT SITE.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 7405951 ↗
• InjuryJan 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH A TOPICAL STEROID (DATE NOT REPORTED).

  Patient problems: Host-Tissue Reaction

  MAUDE report 7181061 ↗