3i T3® BOSS585Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868029595), received between Jan 15, 2020 and May 17, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis

  MAUDE report 19342962 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18948129 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION, IMPLANT REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 16907110 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH #3 WAS PLACED AND TORQUE TESTED. MONTHS LATER THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 14518336 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS, REMOVAL OF THE ABUTMENT AND CLEANING OF THE THREADS, BUT WITHOUT SUCCESS. TOOTH#37.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14100368 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PT PRESENTED PER EMERGENCY APPOINTMENT. IMPLANT #2 HAD CLASS 3 MOBILITY 12MM PROBING DEPTHS AND RADIOGRAPHIC BONE LOSS ON THE APEX. THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. ABSCESS, PAIN AND EDEMA ARE CONSEQUENCES OF THE PERI IMPLANTITIS. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Abscess; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13453256 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED LACK OF PRIMARY STABILITY AND THE IMPLANT WAS REMOVED . THE PATIENT IS RETURNING IN 3 MONTHS FOR IMPLANT PLACEMENT. TOOTH LOCATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698890 ↗
• InjuryJan 15, 2020Adverse 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 9591351 ↗