T3 T3ST511Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868046974), received between Apr 5, 2023 and Apr 24, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #29 AND #30 WERE REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24987340 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. DURING A CHECK-UP DOCTOR NOTICED GREAT MESIAL/DISTAL BONE LOSS DESPITE OF USING THREAD CUTTER. PATIENT HAS BEEN RESCHEDULED FOR BONE REGENERATION AND NEW IMPLANTATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24674665 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER ONE MONTH, THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO BONE LOSS ASSOCIATED WITH INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23977275 ↗
• InjuryAug 19, 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 #30 WAS REMOVED DUE TO INFECTION. IT DID NOT HEAL PROPERLY.

  Patient problems: Unspecified Infection

  MAUDE report 22843586 ↗
• InjuryOct 10, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: Pain

  MAUDE report 20416888 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 4-5 MM OF BONE LOSS. THE IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED. SIGNIFICANT AMOUNT OF BONE LOSS AROUND THE IMPLANT, WHICH RESULTED IN IMPLANT FAILURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20139560 ↗
• InjuryJun 19, 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 #29 EXHIBITED INFLAMED SOFT TISSUE AND CIRCUMFERENTIAL DEFECT, THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19570229 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PLACED IN SITE 6 WAS REMOVED AT POST OP DUE TO INFECTION AND LACK OF STABILITY. PAIN AND INFLAMMATION ALSO REPORTED. BONE DENSITY TYPE III

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 18560362 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #31 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16681716 ↗