3i T3® BOPS4313Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868028413), received between Mar 11, 2020 and Dec 15, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #10. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18333508 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PERI-IMPLANTITIS AND LOSS OF INTEGRATION AROUND THE IMPLANT AT TOOTH LOCATION #8. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16872491 ↗
• InjuryFeb 23, 2022Fracture; Fracture

  DOCTOR REPORTED FRACTURE OF ABUTMENT SCREW AT TOOTH SITE 25. UNABLE TO REMOVED SCREW, IMPLANT WAS ALSO REMOVED. DOCTOR'S ASSISTANT CONFIRMED BY PHONE THAT IMPLANT FRACTURED WHEN REMOVING THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584454 ↗
• InjuryJul 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT AT TOOTH SITE #10 WAS UNABLE TO PLACE DUE TO LACK OF PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186135 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT LACKED PRIMARY STABILITY WHEN PLACING AND IT WAS REMOVED. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Information

  MAUDE report 10726143 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LACKED PRIMARY STABILITY WHEN PLACING IT. PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Information

  MAUDE report 10725834 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN DENTAL SITE 10 WAS REMOVED DUE TO INFECTION.SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND SWELLING.

  Patient problems: Unspecified Infection

  MAUDE report 9816876 ↗