3i T3® BOSS485Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00844868028864), received between Dec 4, 2020 and Jan 21, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Device Damaged by Another Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128247 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND WAS UNABLE TO BITE DOWN COMFORTABLY. AN EXAM & RADIOGRAPHS REVEALED LOSS OF INTEGRATION & MOBILITY OF THE IMPLANT AT TOOTH SITE #30. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23523064 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #45 DETECTED WHILE LOADING THE IMPLANT. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22226799 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #32 DETECTED WHILE LOADING THE IMPLANT . INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22226387 ↗
• InjuryMay 8, 2025Adverse 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 PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21985366 ↗
• InjuryMay 8, 2025Adverse 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 PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21985190 ↗
• 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 20707502 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #27 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20349931 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19403821 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LOCATED AT TOOTH 20 WAS REMOVED DUE TO SECONDARY INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16912284 ↗
• InjuryOct 14, 2022Fracture; Fracture

  DOCTOR REPORTED THE IMPLANT FRACTURED AT TOOTH LOCATIONS 46 AND 44. PATIENT WOULD HAVE TO RETURN TO PLACE NEW IMPLANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608151 ↗
• InjuryOct 7, 2021Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12590106 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 21 WAS REMOVED DUE TO PERI-IMPLANTITIS. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10957440 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION 19 WAS REMOVED DUE TO INFECTION AND BONE LOSS. PATIENT FELT PAIN AND THE SITE INFLAMMATION.

  Patient problems: Inflammation; No Information; Pain; Unspecified Infection

  MAUDE report 10948577 ↗