T3 T3ST411Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00844868046929), received between Sep 23, 2022 and Mar 10, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24562665 ↗
• 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 #24. 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 24277262 ↗
• InjuryNov 25, 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 #14 WAS REMOVED DUE TO INFECTION AND BONE LOSS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23649073 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHORTLY AFTER PLACEMENT THE AREA OF TOOTH SITE #19 BECAME INFECTED AND PAINFUL. AFTER THE TOOTH SITE HEALS, THE IMPLANT WILL BE REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23598433 ↗
• MalfunctionAug 28, 2025Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910642 ↗
• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20976788 ↗
• InjuryNov 26, 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 #8 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT WAS FOUND TO BE INFECTED AND HAD BONE LOSS LESS THAN 1 MONTH POST OP.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20787249 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 LOST 4MM OF BONE AND WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20359304 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED A PERI-IMPLANTITIS AND HE IMPLANT WAS REMOVED. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20255144 ↗
• InjurySep 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DOCTOR REPORTS THAT THE IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO AN ALLERGIC REACTION. THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20224177 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION DESPITE ANTIBIOTICS TREATMENT ET GOOD ORAL HYGIENE. TOOTH LOCATION 33 AND 43. BONE TYPE III. PATIENT HAD PAIN AND SITE PRESENTED AN ABSCESS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18226566 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION DESPITE ANTIBIOTICS TREATMENT AND GOOD ORAL HYGIENE. TOOTH LOCATION 33 AND 43. BONE TYPE III. PATIENT HAD PAIN AND SITE PRESENTED AN ABSCESS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18226532 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17553658 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED #5 AREA SWOLLEN AND SUPPURATION PRESENT; REMOVED AND GRAFTED WITH ALLOGRAFT. THE AREA WAS GRAFTED WITH ALLOGRAFT PRIOR TO THE ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 16308538 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR EXTRACTED THE REMAINING MAXILLARY TEETH AND PLACED A TOTAL OF (6) IMPLANTS. HOWEVER, IMPLANT SITE #9 BECAME FRACTURED AT THE LABIAL CORTICAL PLATE DURING PLACEMENT OF THE IMPLANT. THE IMPLANT WAS NOT STABLE SO IT WAS REMOVED BECAUSE THE DOCTOR STATED THAT THE OTHER (5) IMPLANTS PLACED WERE STABLE AND IN GOOD BONE WHICH SHOULD BE ADEQUATE TO RETAIN THE PROSTHESIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 15474234 ↗