3i T3® BOET413Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00844868033271), received between Jun 18, 2019 and Jan 9, 2026 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT IMPLANTS AT TOOTH SITES #12 AND #22 WERE REMOVED DUE TO PERI-IMPLANTITIS. NEW IMPLANTS WERE PLACED DURING THE SAME PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24026290 ↗
• InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN POSITIONS #46 & #44 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22823794 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 44 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21934652 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 33 AND 43 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21934120 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 33 AND 43 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21934076 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH SITE #34-44-46. PATIENT SUFFERED INFLAMMATION AND PAIN. IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21916654 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE IMPLANTS AT TOOTH SITES 12 AND 14 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21310652 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR WAS REPORTED THAT THE IMPLANTS AT TOOTH #13 AND 15 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21301729 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 7 LACKED PRIMARY STABILITY, AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797601 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITE #16 AND #17 WERE UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY DURING THE SURGERY AND NO OTHER IMPLANT WAS PLACED AFTER THE FIRST ONES FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141652 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITE #16 AND #17 WERE UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY DURING THE SURGERY AND NO OTHER IMPLANT WAS PLACED AFTER THE FIRST ONES FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141622 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD RETURN TO PLACE A NEW IMPLANT ONCE THE SITE HAS REGENERATED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12134179 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD RETURN TO PLACE A NEW IMPLANT ONCE THE SITE HAS REGENERATED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12134081 ↗
• InjuryJun 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072594 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY DURING THE SURGERY AND NO OTHER IMPLANT WAS PLACED AFTER THE FIRST ONE FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861654 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON AVAILABLE INFORMATION, THERE ARE NO SIGNS OF A DEVICE MALFUNCTION. THE EVENT DESCRIPTION IS NOT DEFINED. HOWEVER, THE IMPLANT WAS PLACED (B)(6) 2013 AND WAS EXPLANTED ON (B)(6) 2020. THIS EVENT IS REPORTABLE AS A SERIOUS INJURY DUE TO THE SURGICAL / MEDICAL INTERVENTION REQUIRED TO PRECLUDE / RESOLVE ISSUES ASSOCIATED WITH THE IMPLANT.

  Patient problems: No Information

  MAUDE report 10224315 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 8708336 ↗