3i T3® DCD® BNES465Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868032847), received between Sep 1, 2021 and Apr 9, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 16, 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.

• MalfunctionApr 9, 2026Mechanical Problem

  THE DOCTOR REPORTS THAT THE IMPLANT AT TOOTH SITE 36 HAS A DAMAGED HEXAGON AND WAS REMOVED. NO NEGATIVE IMPACT ON THE PATIENT¿S HEALTH WAS REPORTED AS A CONSEQUENCE OF THE EVENT. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829765 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #36 FAILED DUE TO FRACTURE OF BONE'S WALL DURING IMPLANT PLACEMENT. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. EDEMA WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Bone Fracture(s); Swelling/ Edema

  MAUDE report 21534613 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION 1 FAILED DUE TO PERI-IMPLANTITIS.

  Patient problems: Abscess; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16396482 ↗
• MalfunctionAug 10, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT MOUNT COULD NOT DISENGAGE FROM IMPLANT. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204006 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 21 LACKED PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406551 ↗