3i T3® BOES411Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868032458), received between Aug 28, 2020 and Sep 20, 2023 — classified as 8 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION. TOOTH LOCATION 22.

  Patient problems: Unspecified Infection

  MAUDE report 17784810 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION. TOOTH LOCATION 24.

  Patient problems: Unspecified Infection

  MAUDE report 17780823 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14019959 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BOES411) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 30. INFLAMMATION WAS ALSO NOTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10471243 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT (BOES411) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED.

  Patient problems: No Information

  MAUDE report 10471098 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO BONE LOSS AND INFECTION. AS A CONSEQUENCE OF THE EVENT PATIENT HAD ALSO PAIN.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10470470 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BOES411) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 15. INFLAMMATION WAS ALSO NOTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10468843 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BOES411) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 18. LACK OF IMPLANT STABILITY WAS REPORTED AS A RESULT.

  Patient problems: Unspecified Infection

  MAUDE report 10468734 ↗