3i T3® BOET585Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868033349), received between Mar 30, 2022 and Jun 9, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS PLACED ON (B)(6) 2018. IN 2025, INVISIBLE ORTHODONTIC TREATMENT WAS STARTED. IN 2026, DURING A CHECK-UP, MOBILITY WAS DETECTED. IT¿ WAS NOT THE SCREW, IT WAS THE IMPLANT ITSELF. IT HAS FIBROUS INTEGRATION, AND THE DOCTOR NEEDED TO REMOVE BOTH THE IMPLANT AND THE CROWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25448600 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19741588 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #46/43 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17052481 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 29 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16273452 ↗
• InjuryMar 30, 2022Fracture; Fracture

  IT WAS REPORTED IMPLANT WAS REMOVED WITH TREPHINE DUE TO FRACTURE. THE IMPLANT'S HEXAGON FRACTURED ON THE SAME PLACEMENT DAY AND THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13948795 ↗