T3 T3PT5413Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00844868046783), received between Dec 13, 2022 and Feb 19, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24388728 ↗
• InjuryDec 22, 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 INFECTION. PATIENT PRESENTED FOR FOLLOW UP DUE TO PAIN, PATIENT HAD INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS ABSCESS.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 23871968 ↗
• 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 #5 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS INFLAMMATION, AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 23858514 ↗
• InjuryOct 23, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372617 ↗
• InjuryOct 23, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372384 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT CAME OUT WHEN THE PROTHESIS WAS REMOVED. PATIENT CAME IN WITH BROKEN PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298236 ↗
• InjuryMay 23, 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 NOTED WITH VERTICAL AND PERIAPICAL BONE LOSS. A FULL THICKNESS FLAP WAS REFLECTED AND THE IMPLANT WAS REMOVED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. THERE WAS A LARGE FENESTRATION OF BUCCAL BONE NOTED. THE EXTRACTION SITE WAS SMOOTHED, CURETTED AND IRRIGATED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.

  Patient problems: Osteolysis

  MAUDE report 22079291 ↗
• MalfunctionApr 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DENTIST HAD A HARD TIME SEATING THE CROWN ON THE IMPLANT AT TOOTH LOCATION #14. THE HEX OF THE IMPLANT WAS DAMAGED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892459 ↗
• InjuryJan 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO AN ALLERGIC REACTION. PER PATIENT REQUEST - PATIENT BELIEVED AN ALLERGIC REACTION TO THE IMPLANT WAS PRESENT

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21170312 ↗
• InjuryJan 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # WAS REMOVED DUE TO AN ALLERGIC REACTION. PER PATIENT REQUEST - PATIENT BELIEVED AN ALLERGIC REACTION TO THE IMPLANT WAS PRESENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21169242 ↗
• InjuryJan 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED DUE TO AN ALLERGIC REACTION. PER PATIENT REQUEST - PATIENT BELIEVED AN ALLERGIC REACTION TO THE IMPLANT WAS PRESENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21168811 ↗
• InjuryJul 16, 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 #4 WAS REMOVED DUE TO INFECTION. PATIENT WAS EXPERIENCING PAIN AROUND IMPLANT #4. IMPLANT WAS REMOVED AND BONE GRAFT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19756721 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PT HAD DISCOMFORT IN IMPLANT TOOTH SITE #5 AROUND IMPLANT AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. DISCOMFORT.

  Patient problems: Discomfort; Osteolysis; Pain

  MAUDE report 18873595 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TOOTH WAS REMOVED USING ELEVATORS AND FORCEPS WITH COMPLICATION. DECORTICATED. THE OSTEOTOMY WAS PREPARED USING OSTEOTOMES. NO SCOUT FILM WAS OBTAINED. NO SURGICAL GUIDE WAS USED. A ZB TAPERED 5/4X13 MM IMPLANT WAS PLACED. TORQUED 40 NCM. CO/CA/XE REGENEROSS BONE WAS USED TO GRAFT THE PERI-IMPLANT DEFECT. AN ENCODE 465 HEALING ABUTMENT WAS PLACED. ON (B)(6) 2023 PATIENT RETURNED FOR SURGICAL RELEASE SITE #4 AND INSTRUCTED TO CONTINUE CARE WITH DR. ON (B)(6) PATIENT CALLED OUR OFFICE STATING DENTIST DISCOVERED AN INFECTION AT SITE #4 DURING ROUTINE CLEANING. ON (B)(6), PATIENT WERE EVALUATED IN OUT OFFICE AND THERE WAS A 6MM PROBING DEPTH ON THE DL WITH A PARULIS ON THE FACIAL. IN NOV A FULL THICKNESS FLAP WAS REFLECTED. IMPLANT WAS REMOVED USING A TREPHINE BURR AND FORCEPS, THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO THE HEALTHY BONE. SITE WAS SMOOTH, IRRIGATED, DECORTICATED. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE EXTRACTION SITE. APRF MEMBRANE WAS PLACED OVER THE GRAFT.

  Patient problems: Unspecified Infection

  MAUDE report 18377547 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTIST DIDN'T LIKE THE PLACEMENT OF THE IMPLANT AT TOOTH SITE #4 AND REQUESTED THAT IT BE PLACED AS A MORE DISTAL POSITION. TOOTH SITE #4. PROCEDURE WAS COMPLETED WITH A T3PT4311.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050671 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS WITH TENDERNESS AND INFLAMMATION AT IMPLANT TOOTH SITE #6. THEREFORE, THE IMPLANT WAS REMOVED, AND THE SITE WAS GRAFTED WITH ALLOGRAFT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17612165 ↗
• InjuryJun 30, 2023Mechanical Problem; Mechanical Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243571 ↗
• InjuryApr 10, 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: Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16710045 ↗
• InjuryApr 10, 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: Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16710012 ↗
• InjuryDec 13, 2022Adverse 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 PAIN. THE PATIENT REPORTED CONTINUOUS PAIN AT IMPLANT SITE SO IT WAS DECIDED TO REMOVE THE IMPLANT.

  Patient problems: Pain

  MAUDE report 15970809 ↗