3i T3® BOPS5485Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868028451), received between Mar 1, 2021 and Jul 30, 2026 — 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.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported severe pain following implant placement at tooth site 26; no improvement in the pain despite antibiotic treatment and the implant was removed. Symptom-free 10 days after implant removal.

  Patient problems: Pain

  MAUDE report 50080383 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 23075492 ↗
• InjuryFeb 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 SITES #4 AND #13 WERE REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16285698 ↗
• InjuryJan 9, 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 MEDICAL BONE LOSS AND MEDICAL INFECTION. PAIN AND INFLAMMATION ARE REPORTED SYMPTOMS. THE AREA WAS GRAFTED WITH ALLOGRAFT PRIOR ORIGINAL IMPLANT PLACEMENT. TOOTH SITE #18 (UNIVERSAL).

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16120298 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED INFECTION, FINAL TORQUE TEST OF IMPLANT. THE IMPLANT WAS REMOVED. TOOTH 14.

  Patient problems: Unspecified Infection

  MAUDE report 14362512 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BOPS5485 IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH SITE # 18 (UNIVERSAL). SITE WAS GRAFTED WITH XENOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT. INFLAMMATION IS REPORTED AS SYMPTOM.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 11728529 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED PERSISTENT INFECTION AFTER THE CROWN WAS PLACED. THE IMPLANT AT TOOTH SITE #31 FAILED DUE TO INFECTION AND BONE LOSS AND WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11392512 ↗