T3 T3PT4315Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868046745), received between Jan 3, 2024 and Sep 15, 2026 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the implant at tooth site #26 was removed due to significant vertical and periapical bone loss associated with the implant, extending to tooth #27, with a facial parulis noted at the implant site. During the surgical appointment on (b)(6) 2026, the healing abutment was removed, and the implant was removed using reverse torque. The osteotomy was debrided of soft tissue to healthy bone and grafted with bone graft material mixed with PRF exudate. A PRF membrane was placed over the graft, and the soft tissues were reapproximated with sutures. A 3 mm buccal bone dehiscence was noted, while the remaining bony walls were intact.

  Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 50770544 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED IN ORDER TO REPLACE THE IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24338599 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

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

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

  MAUDE report 23980207 ↗
• InjuryJul 17, 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 #28 WAS REMOVED DUE TO INFECTION. PATIENT HAS IMPLANT #28 PROCEDURE DONE AFTER A PREVIOUS FAILURE IN THE SAME SITE. HE PRESENTED TO THE OFFICE FOR A 2 WEEK POST OP APPOINTMENT; TISSUE WAS NOTED AS PUFFY & TENDER ON THE BUCCAL POST OP X-RAY SHOWS IMPLANT WITH LUCENCY. RX FOR AUGMENTIN FOR 8 DAYS. PATIENT RETURNED TO OFFICE 6 DAYS LATER FOR IMPLANT REMOVAL. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22530163 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OFFICE FOR A TWO (2) WEEK POST OP APPOINTMENT. TISSUE WAS NOTED AS PUFFY AND TENDER ON THE BUCCAL AND THE POST OP X-RAY SHOWED LUCENCY AROUND THE IMPLANT AT TOOTH LOCATION #28. ANTIBIOTIC (AUGMENTIN) WAS PRESCRIBED FOR EIGHT (8) DAYS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS

  Patient problems: Discomfort; Swelling/ Edema; Unspecified Infection

  MAUDE report 22518821 ↗
• InjuryMay 7, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21979830 ↗
• InjuryApr 26, 2025Adverse 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: Osteolysis; Swelling/ Edema

  MAUDE report 21915402 ↗
• InjuryDec 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOOTH 20 HAD NERVE INJURY. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PARESTHESIA. NO SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE. NO DELAY. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. ADDITIONAL APPOINTMENT WAS REQUIRED TO PLACE ADDITIONAL IMPLANTS.

  Patient problems: Nerve Damage; Paresthesia

  MAUDE report 20932574 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOV 13, 2024: SPOKE TO REPORTER WHO STATED THE ANTIBIOTICS WERE PRESCRIBED ON (B)(6) 2023 AS PREVENTIVE & ON (B)(6) 2024 WHEN THE IMPLANT WAS REMOVED. IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS & INFECTION. ACTIVE INFECTION AND BONE LOSS AT IMPLANT #3 DUE TO IMPLANT CROWN BEING A FOOD TRAP. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: YES, BONE GRAFT AT SITE #3. ADDITIONAL APPOINTMENT REQUIRED: YES, POSSIBLE REPLACEMENT OF IMPLANT #3. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20761962 ↗
• 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20568456 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT ABOUT 2 WEEKS AFTER PLACEMENT OF IMPLANT AT TOOTH SITE #12, THE PT STARTED HAVING PAIN AND SWELLING. PATIENT WAS GIVEN ANTIBIOTICS, CLINDAMYCIN PRESCRIBED FOR INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. INFLAMMATION. ABSCESS.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19939097 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH FACIAL SWELLING, ACUTE SUBPERIOSTEAL ABSCESS. TOOTH #21. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19700498 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN REPORTED PATIENT HAD A SINUS TRACT ASSOCIATED WITH THE AREA. DURING IMPLANT STABILITY TEST, IT WAS DEEMED FAILED AND WAS REMOVED. NOTED INFECTION, ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 19511564 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #6 & #10 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19019078 ↗
• InjuryMar 25, 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 # 6 WAS REMOVED DUE TO INFECTION. IMPLANT NOTED WITH MOBILITY AFTER CROWN WAS PLACED. IMPLANT WAS REMOVED USING A RONGUER AND 0.5CC PUROS CANCELLOUS BONE GRAFT WAS PLACED IN SITE.

  Patient problems: Unspecified Infection

  MAUDE report 18976282 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED PARULIS BUCCAL AREA OF IMPLANT #12 FIVE WEEKS AFTER PLACEMENT. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES. ADDITIONAL APPOINTMENT REQUIRED: NOT YET. PLAN TO REPLACE IN 3 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18441270 ↗