T3 T3PT6515Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868046844), received between Mar 28, 2024 and Sep 14, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an apical radiolucency consistent with bone loss was observed in association with the implant at tooth site 19. The crestal bone appeared intact. The implant was subsequently removed.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50755078 ↗
• InjuryApr 25, 2025Adverse 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: Osteolysis

  MAUDE report 21912039 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT #17 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21276728 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AND INFECTION AT IMPLANT TOOTH SITE #19, WITH ASSOCIATED ABSCESS. THE PATIENT RETURNED TO THE CLINIC FOR STAGE II, A FULL THICKNESS FLAP WAS REFLECTED, AND IMPLANT WAS EXPOSED, A SMALL AMOUNT OF PURULENCE WAS ENCOUNTERED. A BONY SEQUESTRUM ON THE FACIAL WAS REMOVED, THERE WAS A BONY DEFECT ON THE DENTAL AND FACIAL ASPECTS OF THE IMPLANT. A TREPHINE BUR WAS USED TO REMOVE THE IMPLANT, SMOOTHED, CURETTED AND IRRIGATED. DECORTICATED CO/CA/XE RENEGORSS BONE WAS USED TO GRAFT THE SITE. SOFT TISSUES WERE RE-APPROXIMATED USING 4-0 CHORMIC SUTURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18990609 ↗