3i T3® BOST515Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868029687), received between Nov 22, 2019 and Dec 23, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Mechanical 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877882 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #12 WAS REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15600724 ↗
• InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS THEY HAVE AN IMPLANT AT TOOTH LOCATION #12 THAT HAS DEVELOPED INFECTION. SITE GRAFTED AFTER IMPLANT REMOVAL. PATIENT WILL RETURN IN 4 MONTHS TO REPLACE.

  Patient problems: Unspecified Infection

  MAUDE report 11426658 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION 9. PAIN, INFLAMMATION, AND EDEMA WERE REPORTED.

  Patient problems: Edema; Inflammation; Pain; Unspecified Infection

  MAUDE report 10835870 ↗
• InjuryOct 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BOST515 IMPLANT HAD TO BE REMOVED DUE TO INFECTION AND BONE LOSS. ABSCESS, EDEMA AND INFLAMMATION IS ALSO REPORTED. TOOTH SITE # 29.

  Patient problems: Abscess; Edema; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10660129 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POST OP INFECTION AT TOOTH SITE # 9. PATIENT EXPRESSED PAIN, SWELLING, LOOSE, TEMP WITHIN 1 WEEK POST SURGERY. IMPLANT REMOVED SITE GRAFTED. PATIENT TO RETURN IN 3 MONTHS FOR IMPLANT RE PLACEMENT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, BONE LOSS, DEHISCENCE, INFLAMMATION, EDEMA & PAIN.

  Patient problems: Edema; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 9896849 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BOST515) WAS REMOVED DUE TO INFECTION AND MOBILITY AT TOOTH LOCATION 8. INFLAMMATION AND PAIN WAS ALSO REPORTED. SITE WAS BONE GRAFTED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 9363840 ↗