3i T3® BOPS4385Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868028420), received between Apr 1, 2020 and Sep 20, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 12 AND 14 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 15457037 ↗
• InjurySep 16, 2022Adverse 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. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 15435979 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 FAILED TO INTEGRATE DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13367149 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 21 FAILED TO INTEGRATE DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13367144 ↗
• InjuryJul 9, 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 INFECTION.

  Patient problems: Abdominal Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 12147398 ↗
• InjuryApr 29, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11746584 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT(S) AT TOOTH SITE(S) # 4 FAILED DUE TO INFECTION AT THE IMPLANT SITE. THE IMPLANT WAS REMOVED. PATIENT PRESENTS TO OFFICE FOR OBSERVATION WITH VISUAL FISTULA, THEREFORE THE IMPLANT NEED TO BE REMOVED, SITE WAS GRAFTED PRIOR TO PLACEMENT. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION AND PAIN.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9913209 ↗