3i T3® BOET485Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00844868033295), received between Nov 26, 2019 and May 5, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 46 AND 47 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN AND DISCOMFORT WHEN CHEWING. PROSTHESIS WAS REMOVED, DOCTOR NOTICED MOBILITY AND REMOVED IMPLANTS WITH FORCEPS. THERE WAS NO SUPPURATION. DOCTOR PERFORMED CURETTAGE AND PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANTS PLACEMENT IN 2 MONTHS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21958505 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #46 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21310591 ↗
• InjuryFeb 3, 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 21293756 ↗
• 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 #(B)(6) WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17052437 ↗
• InjuryJan 20, 2023Adverse 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. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16216562 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 16090985 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WAS REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14369349 ↗
• InjuryJan 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT CAME WITH A FALLEN PROSTHESIS AND A BROKEN PROSTHESIS HOLDING SCREW, THE IMPLANT IS ALSO FRACTURED. IMPLANT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257037 ↗
• InjuryDec 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 28 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13038508 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE IMPLANT LOCATED IN DENTAL POSITION #45 COULD NOT BE PLACED BECAUSE IT DID NOT OBTAIN PRIMARY STABILITY. THE DOCTOR CONFIRMS THAT THE DENTAL SURGICAL PROCEDURE WAS NOT CONCLUDED WITH ANOTHER IMPLANT IN THE SAME SURGERY. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796039 ↗
• 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 # 9, 10 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12445540 ↗
• 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 # 9, 10 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12445521 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING IMPLANT PLACEMENT. DOCTOR DID NOT COMPLETE THE PROCEDURE PLACING OTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133902 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING IMPLANT PLACEMENT. DOCTOR DID NOT COMPLETE THE PROCEDURE PLACING OTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133875 ↗
• MalfunctionSep 7, 2020Device Damaged by Another Device; Device Damaged by Another Device

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

  Patient problems: No Information

  MAUDE report 10498900 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON PLACEMENT OF THE IMPLANT, THE IMPLANT COULD NOT ACHIEVE PRIMARY STABILITY AND WAS REMOVED. ANOTHER IMPLANT WAS NOT PLACED.

  Patient problems: No Information

  MAUDE report 9378306 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON PLACEMENT OF THE IMPLANT, THE IMPLANT COULD NOT ACHIEVE PRIMARY STABILITY AND WAS REMOVED. ANOTHER IMPLANT WAS NOT PLACED.

  Patient problems: No Information

  MAUDE report 9378263 ↗