T3 T3ST3215Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868046899), received between Jun 4, 2024 and Apr 15, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO EXTENSIVE BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24889046 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT DEVELOPED AN INFECTION AFFECTING IMPLANT. IMPLANT REMOVED / GRAFTED. WILL REPLACE IN 3 MONTHS. TOOTH NUMBER 23.

  Patient problems: Unspecified Infection

  MAUDE report 24484484 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24368510 ↗
• InjuryDec 16, 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: Inflammation; Osteolysis; Pain

  MAUDE report 23821432 ↗
• InjurySep 16, 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 #10 WAS REMOVED DUE TO BONE LOSS. (B)(6) 2025 #10 12MM PROBING DEPTHS ON THE DISTAL & 10MM PROBING DEPTH ON THE MESIAL. THERE IS EVIDENCE OF BONE LOSS ALONG THE AXIAL SURFACE OF THE IMPLANT. INTEGRATED IMPLANT AT SITE #10 WITH VERTICAL BONE LOSS. (B)(6) 2025 #10 HEALING ABUTMENT WAS REMOVED. IMPLANT WAS REMOVED USING REVERSE TORQUE. A FULL THICKNESS FLAP WAS REFLECTED. THERE WAS 6MM DEHISCENCE OF BUCCAL BONE NOTED. ALL OTHER BONY WALLS REMAINED INTACT. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. CO/CAXA REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE OSTEOTOMY & BUCCAL DEFECT. A PRF WAS PLACED OVER THE SITE. SOFT TISSUE WERE RE APPROXIMATED USING 3-0 GUT SUTURE. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO, ONLY GRAFTING WAS COMPLETED. PATIENT WILL RETURN FOR IMPLANT PLACEMENT. ADDITIONAL APPOINTMENT REQUIRED: YES, ONLY GRAFTING WAS COMPLETED. PATIENT WILL RETURN FOR IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 23061618 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED HAVING SYMPTOMS THAT BECAME PROGRESSIVELY WORSE WITH PARULIS ON TOP OF THE IMPLANT AT TOOTH SITE #23. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22923225 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20555478 ↗
• InjuryJun 4, 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 # 7 WAS REMOVED DUE TO INFECTION ABSCESS PRESENT, THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT AND AFTER REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 19459262 ↗