3i T3® BOES410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868032441), received between Mar 3, 2020 and Sep 20, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Separation Failure” (1 report).

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 4 most recent of 4 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 14.

  Patient problems: Unspecified Infection

  MAUDE report 17785765 ↗
• InjuryApr 7, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT DR. INDICATED MALFUNCTION. THE DOCTOR TRIED TO REMOVE THE MOUNT, BUT IT DID NOT COME OFF AND THE IMPLANT BODY WAS REMOVED. IT HAS BEEN TREATED AND IS NOT RE-EMBEDDED. SCHEDULED TO BE EMBEDDED AT A LATER DATE. NO HEALTH HAZARD. MALFUNCTION, DOES NOT COME OFF THE MOUNT. TOOTH SITE # 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046121 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT (BOES410 ) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND IT WAS REMOVED. SITE WAS BONE GRAFTED. TOOTH LOCATION 9.

  Patient problems: No Information

  MAUDE report 9979473 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT COULD NOT ACHIEVE PRIMARY STABILITY. THE IMPLANT WAS REMOVED AND NO OTHER IMPLANT WAS PLACED. TOOTH LOCATION 30.

  Patient problems: No Information

  MAUDE report 9782505 ↗