3i T3® BOSS313Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868028772), received between Nov 13, 2020 and Nov 18, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #35/36 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20707653 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WOULD NOT SEAT DUE TO BUCCAL BONE LOSS AT THE SITE. THE PROCEDURE WAS NOT COMPLETED USING ANOTHER DEVICE.

  Patient problems: Osteolysis

  MAUDE report 15454699 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BOSS313 IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH SITE # 5.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11542795 ↗
• InjuryNov 13, 2020Adverse 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 SURGERY AND WAS REMOVED.

  Patient problems: No Code Available

  MAUDE report 10834955 ↗