T3 T3PT5410Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00844868046769), received between Jan 9, 2023 and Sep 30, 2026 — classified as 76 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant was removed due to bone loss. After multiple gingival graft around the implant at tooth site 14, top of the treads of the implant was still exposed and visible. Implant removed and another implant was placed deeper.

  Patient problems: Osteolysis

  MAUDE report 50945405 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with discomfort at implant site. Clinical exam shows purulence and radiograph shows infection surrounding implant. Implant removed, site debrided and grafted.

  Patient problems: Discomfort; Purulent Discharge; Unspecified Infection

  MAUDE report 50945218 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient came to office with pain at #30 implant and was removed due to infection.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50944830 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a Peri-implantitis at tooth site 31. Patient presented with a fistula on gingiva 4 months after placement, planned to bring back to flap and debride implant. During debridement procedure, bone loss was too extensive, so implant was removed.Inflammation, fistula and abscess were reported as a consequence.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 50815657 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant was removed due to Peri-implantitis at tooth site #19. Discovered upon check up, the implant was removed and bone graft placed. Patient will come back in 3 months for new implant placement. Inflammation and abscess reported as a result of the event.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50815572 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that two implants at tooth sites 27 and 30 were removed due to a large bone loss and an infection.Sites were grafted and patient will return in 4 months to place a new implants.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50799076 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to distal bone loss and infection. The patient had complained of implant #31 being loose and hurting. The infection was cleaned out, and the site was grafted. Patient will return in 5 months to place a new implant.Pain was reported as a consequence.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50799028 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported peri-Implantitis, Loss integration and bone loss at tooth site 26. On examination the area looked inflamed, tender to examine, bone loss found around the implant. Symptoms Pain, inflammation. Planning to replace the implant later this year.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50266935 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE WAS REMOVED AND SITE GRAFTED DUE TO INFECTION. PATIENT WILL RETURN TO REDO IMPLANT. NOTED ABSCESS AND INADEQUATE ORAL HYGIENE.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 25399912 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS. LACK OF TISSUE COVERING BUCCAL ASPECT OF IMPLANT. THE IMPLANT WAS DEBRIDED AND CONNECTIVE TISSUE GRAFT WAS DONE FOR #3 IMPLANT ON BUCCAL DUE TO EXPOSED IMPLANT THREADS.

  Patient problems: Osteolysis

  MAUDE report 25191399 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS & INFECTION IN THE SINUS CAVITY.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24957188 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INDIRECT SINUS AT THE IMPLANT PLACEMENT PROCEDURE AT TOOTH SITE #14. AFTER THE SURGERY, THE PATIENT DEVELOPED A SINUS INFECTION. THE PATIENT WAS NOT CALLED BACK BECAUSE THEY WERE ALREADY ON ANTIBIOTICS. IT WAS NOTED THAT THERE WAS NOT DRAINAGE AT THE SITE. THE PATIENT RETURNED FOR A THREE-MONTH EXAMINATION. THE PATIENT HAD FAILED TO CONTACT THE CUSTOMER ABOUT THE SINUS INFECTION THAT SHE HAD POST-OPERATION. THE PATIENT COMPLAINED THAT THE IMPLANT BECAME LOOSE AND UNCOMFORTABLE. THE PATIENT ARRIVED TO AN EXAMINATION ON (B)(6) 2026 WITH THE IMPLANT IN THEIR HAND, WHICH HAD CAME OUT AT THEIR HOME WHILE EATING BANANA NUT BREAD. THIS OCCURRED THE DAY BEFORE THE APPOINTMENT. THE SITE WAS LEFT TO HEAL FOR A MONTH, AFTER WHICH, A REPLACEMENT PROCEDURE WAS ANTICIPATED. THE CUSTOMER ALSO EXPRESSED THAT THERE WAS NO SINUS PREFORMATION NOTED AND THAT IT WAS UNKNOWN WHAT CAUSED THE IMPLANT FAILURE. SYMPTOMS AS A RESULT OF THE EVENT: SINUS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24899189 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANT AT TOOTH SITE #19 PLACED ON (B)(6) 2025. THE PATIENT RETURNED FOR A SECOND STAGE UNCOVER PROCEDURE APPOINTMENT ON (B)(6) 2026. BONE LOSS WAS NOTED. THE SITE WAS GRAFTED AND LEFT TO HEAL FOR ANOTHER THREE MONTHS. THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND THE AREA WAS GRAFTED AGAIN. AN ADDITIONAL APPOINTMENT IS ANTICIPATED TO REPLACE THE IMPLANT AFTER APPROXIMATELY FIVE MONTHS.

  Patient problems: Osteolysis

  MAUDE report 24865839 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 FAILED DUE TO PERI-IMPLANTITIS. NEW IMPLANT AND CROWN WILL NEED TO BE PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24799597 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 24595224 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24364912 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME INTO THE OFFICE WITH THE IMPLANT AT TOOTH SITE #30 OUT OF THEIR MOUTH. THE IMPLANT CAME OUT DUE TO INFECTION. DEBRIDEMENT WAS NEEDED IN THE AREA OF THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 24298710 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS REMOVED DUE TO LOSS OF BONE INTEGRATION AND PERI-IMPLANTITIS SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24232994 ↗
• MalfunctionJan 14, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072976 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO BONE LOSS WHICH SURROUNDED THE IMPLANT LEADING TO OSTEOINTEGRATION. AN ADDITIONAL APPOINTMENT WAS REQUIRED.

  Patient problems: Osteolysis

  MAUDE report 24072747 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO BONE LOSS WITH DEEP POCKETS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 24031500 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS WAS PRESENT ON THE DISTAL OF THE IMPLANT AT TOOTH SITE #4, AFFECTING THE SINUS. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24021553 ↗
• InjuryDec 31, 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 #4 WAS REMOVED WITH DEBRIDEMENT DUE TO PERIIMPLANTITIS. SIGNIFICANT GRANULATION TISSUE FOUND BETWEEN IMPLANT AND BUCCAL CORTICAL PLATE REQUIRING IMPLANT REMOVAL. AN ADDITIONAL APPOINTMENT IS ANTICIPATED APPROXIMATELY FOUR MONTHS FROM THE IMPLANT REMOVAL DATE FOR AN IMPLANT REPLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23936038 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 15 HAD TO BE REMOVED DUE TO PAIN DURING THE PLACEMENT OF THE CROWN. THE DOCTOR ALSO REPORTS DISCOMFORT. THE DOCTOR INDICATES THAT THE PATIENT IS IN GOOD HEALTH CONDITION. PROCEDURE WAS COMPLETED.

  Patient problems: Discomfort; Pain

  MAUDE report 23568222 ↗
• InjuryOct 29, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT SITE BECAME PAINFUL AND ERYTHEMA WAS NOTED. SYMPTOMS AS A RESULT OF THE EVENT WERE INFLAMMATION, PAIN, AND SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 23418591 ↗