T3 T3PT5415Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844868046790), received between Oct 30, 2023 and Dec 20, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 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 #22 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 23858511 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTIC FOR AN INFECTION. PATIENT RETURNED AT 4 WEEKS POST OP STATING HE STOPPED TAKING THE AUGMENTIN AFTER 4 DAYS BECAUSE IT MADE HIM FEEL DIZZY. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 22579803 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED SIX (6) WEEKS POST OP IMPLANT PLACEMENT AT TOOTH SITE #29 WITH BUCCAL SWELLING. A CT SCAN REVEALED ABSCESS EXTENDING TO THE MENTAL FORAMEN. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22575342 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED THREE (3) WEEKS POST OP IMPLANT PLACEMENT AT TOOTH LOCATION #29 COMPLAINING OF TENDERNESS. THE DOCTOR NOTED THAT THE IMPLANT WAS STABLE WITH POSSIBLE ABSCESS. THE PATIENT WAS PRESCRIBED AUGMENTIN FOR 7 DAYS DUE TO INFECTION.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 22575159 ↗
• InjuryJun 23, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A SINUS LIFT WAS PERFORMED SIX (6) MONTHS PRIOR TO IMPLANT PLACEMENT AT TOOTH SITE #14. THE IMPLANT WAS DISPLACED INTO SINUS WHEN PLACING THE ABUTMENT. ENTERED THE LEFT SINUS TO RETRIEVE THE IMPLANT AND ABUTMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22309705 ↗
• InjuryJun 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 #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22285530 ↗
• InjuryOct 30, 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: Osteolysis; Unspecified Infection

  MAUDE report 20568580 ↗
• InjuryAug 14, 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 HAD INFECTION. SWELLING AROUND LATERAL SURFACE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19984237 ↗
• InjuryApr 2, 2024Adverse 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 INFECTION. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19019298 ↗
• InjuryOct 30, 2023Adverse 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 BONE LOSS. TOOTH SITE #6.

  Patient problems: Osteolysis

  MAUDE report 18031552 ↗