T3 T3ST413Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00844868046936), received between Oct 10, 2022 and Sep 29, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The doctor reports that the dental implant failed due to peri-implantitis, tooth site 26.The doctor reports in the PER that the procedure was concluded by placing another implant. Pain and inflammation reported as a consequence.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50931391 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the dental implant failed due to peri-implantitis. Pain was also reported.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50052362 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25111182 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25111063 ↗
• 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 24376400 ↗
• 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 24376223 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION WITHIN A FEW WEEKS OF IMPLANT PLACEMENT AT TOOTH SITE #28. THE IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24277355 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain

  MAUDE report 24256851 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24021258 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE: # 9.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21948671 ↗
• InjuryFeb 18, 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 #11 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21399995 ↗
• MalfunctionJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 FELL TO THE FLOOR. IT WAS REPLACED WITH ANOTHER IMPLANT IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472852 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT SITE #12 WAS REMOVED DUE TO DISCOMFORT AND PAIN IN AREA. SITE GRAFTED (B)(6) 2022. PATIENT REPORTED PAIN IN SITE OF IMPLANT. WHEN IMPLANT WAS REMOVED, GRANULATED TISSUE PRESENT IN OSTEOTOMY. SITE WAS DEBRIDED. ALLOGRAFT WAS PLACED (B)(6) 2022.

  Patient problems: Discomfort; Pain

  MAUDE report 18879343 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED PAIN IN AREA OF THE IMPLANT AT TOOTH SITE #12. GRANULATION TISSUE WAS PRESENT IN THE OSTEOTOMY AREA, THEREFORE THE IMPLANT WAS REMOVED AND THE AREA WAS DEBRIDED.

  Patient problems: Pain

  MAUDE report 18624180 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED INFECTION AND BONE LOSS AROUND IMPLANT T3ST413. THREE DENTAL IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS IN EARLY STAGE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17883630 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT IMPLANT TOOTH SITE #20. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 17796045 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AND INFECTION AT TOOTH SITE # 9. THE IMPLANT WAS REMOVED, AND THE AREA GRAFTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17080460 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Discomfort; Pain

  MAUDE report 16617584 ↗
• InjuryMar 16, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16559826 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # (UNKNOWN) WAS REMOVED DUE TO PERI-IMPLANTITIS. ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND MOBILITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16096283 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BONE FRACTURED AT BUCCAL ON OSTEOTOMY SITE 6 RESULTING IN LACK OF STABILITY OF IMPLANT FOLLOWING PLACEMENT. ALTERNATE SITE USED (SITE 2) TO PLACE ANOTHER IMPLANT FOR RETAINING REMOVABLE PARTIAL DENTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15570616 ↗