T3 T3ST513Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868046981), received between Jul 24, 2024 and Apr 27, 2026 — classified as 6 injuries, 1 malfunction.

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.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SEVERE BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #29. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25008267 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD INFLAMMATION AND TOOK ANTIBIOTICS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24376129 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 13 HAD A CHRONIC INFECTION AFTER PLACEMENT. REMOVED AND GRAFTED. WILL COME BACK FOR REVISION IN 6 MONTHS. TYPE 3 BONE ALLOGRAFT PLACED WITH IMPLANT PLACEMENT. NOTED RA, PAIN AND EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24334945 ↗
• MalfunctionNov 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED IMPLANT PLACED, STRONG PRIMARY STABILITY. COULD NOT SEAT ENCODE (PLATFORM CLEAR). IMPLANT REMOVED. STILL COULDN'T SEAT ENCODE. PLACE ANOTHER T3ST513 IN SITE AND ENCODE SEATED PERFECTLY. POSSIBLE MANUFACTURER DEFECT. TOOTH 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450157 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema

  MAUDE report 22065297 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 20249710 ↗
• InjuryJul 24, 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 #30 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19819823 ↗