3i T3® BOET411Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00844868033264), received between Aug 5, 2020 and Aug 16, 2025 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• 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 22823793 ↗
• 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 21310798 ↗
• 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 21301739 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE IMPLANTS AT TOOTH #43 AND #46 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21301645 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2 IMPLANTS WERE REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 44 AND 42.

  Patient problems: Osteolysis

  MAUDE report 20405424 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION AT TOOTH SITE 32. DRAINAGE WAS PERFORMED TO AVOID A POSTERIOR DAMAGE. IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES.

  Patient problems: Unspecified Infection

  MAUDE report 20043209 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH 12 AND 14 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED ON THE SAME PROCEDURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18553892 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH 22 AND 24 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED ON THE SAME PROCEDURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18553780 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH 12 AND 14 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED ON THE SAME PROCEDURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18553778 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH 22 AND 24 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED ON THE SAME PROCEDURE

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18553604 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO OTHER IMPLANT WAS PLACED ON THE SAME PROCEDURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18550779 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #46 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17406401 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17361915 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17360958 ↗
• MalfunctionApr 14, 2023Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743363 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. SUPPURATION AND ABSCESS WERE ALSO REPORTED AS A RESULT OF THE EVENT. TOOTH LOCATIONS UNKNOWN.

  Patient problems: Abscess; Fluid Discharge; Unspecified Infection

  MAUDE report 16088318 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. SUPPURATION AND ABSCESS WERE ALSO REPORTED AS A RESULT OF THE EVENT. TOOTH LOCATIONS UNKNOWN.

  Patient problems: Abscess; Fluid Discharge; Unspecified Infection

  MAUDE report 16088264 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITE 44 WITH MARGINAL BONE LOSS, ABCESS, EDEMA, INFLAMMATION AND PAIN. PATIENT IS SMOKER.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 13665526 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13421926 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED DUE TO PERI-IMPLANTITIS. ANOTHER IMPLANT WOULD BE PLACED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13421866 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 13421299 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 21 & 19 WERE REMOVED DUE TO INFECTION. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13026203 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 21 & 19 WERE REMOVED DUE TO INFECTION. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13026090 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 12, 14 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12445762 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE #23 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 12141896 ↗