3i T3® BOST613Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868029724), received between Oct 4, 2021 and Feb 21, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 30 WAS REMOVED DUE TO INFECTION. PATIENT HAD PAIN AND DISCOMFORT AT SITE. NOTED INFLAMMATION. SITE GRAFTED: MINEROSS/PURAGRAFT. WILL RETURN IN 3 MONTHS FOR NEW IMPLANT.

  Patient problems: Discomfort; Inflammation; Pain; Unspecified Infection

  MAUDE report 16408553 ↗
• InjuryNov 29, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #18 LOSS STERILITY. IT WAS ALSO INDICATED A SERIOUS INJURY OCCURRED AND THE IMPLANT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882599 ↗
• InjuryNov 6, 2022Adverse 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 AT THE IMPLANT SITE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15741409 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT ON TOOTH SITE #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15237295 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 3 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12748961 ↗
• InjuryOct 4, 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 SITE #19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571832 ↗