3i T3® BOSS611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868029618), received between Aug 13, 2021 and Oct 21, 2021 — classified as 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 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 UNABLE TO PLACE: "POOR BONE DENSITY". NO SYMPTOMS WAS REPORTED. PATIENT WILL RETURN FOR AN ADDITIONAL APPOINTMENT FOR BONE GRAFTING. TOOTH #30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672412 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH THE IMPLANT IN TOOTH SIT #19 (UNIVERSAL). IMPLANT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321524 ↗