T3 T3PT5411Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00844868046776), received between Jun 28, 2023 and Sep 17, 2026 — classified as 54 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a bone loss and an infection. Tooth site 4, site was grafted.Pain and swelling reported as a consequence.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 50799198 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 18 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANTATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24647268 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. IMPLANT FAILED / BONE LOSS. TOOTH #30.

  Patient problems: Osteolysis

  MAUDE report 24520831 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 24441775 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO ONGOING PAIN. THE PATIENT WAS CONCERNED THAT THE IMPLANT HAD BEEN POSITIONED TOO DEEPLY AND WAS CONTRIBUTING TO THE PAIN. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED IN ORDER TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 24390021 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. AFTER PLACEMENT OF IMPLANT, NOTED ON (B)(6) 2023 INCOMPLETE BONE MATURITY ON MESIOAPICAL. ON (B)(6) 2024 DEBRIDED AND SMOOTHED THREADS FACIAL AND MESIAL. ON (B)(6) 2025. PATIENT STATES STILL NOT RIGHT AND NOTED EXUDATE. PLACED ON ANTIBIOTICS. COMPLETELY FAILED ON (B)(6) 2026 AND REMOVED AND GRAFTED. TOOTH NUMBER 4. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24348646 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24069090 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION. FISTULA NOTICED ON AND OFF BEFORE IMPLANT WAS RESTORE BY DENTIST. MUSHY TISSUE NOTICED FACIAL TO IMPLANT AND MICRO MOVEMENT. IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 24042207 ↗
• InjuryDec 30, 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

  MAUDE report 23923372 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LOT OF INFLAMMATION AROUND THE IMPLANT AT TOOTH SITE #19, MAKING IT VERY PAINFUL AND SORE. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23732660 ↗
• InjuryDec 5, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725430 ↗
• InjuryNov 14, 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

  MAUDE report 23559967 ↗
• InjuryNov 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 #13 WAS REMOVED DUE TO INFECTION. ON (B)(6) 2025, A SUBPERIOSTEAL INFECTION WAS NOTED AT SITE #13. A VESTIBULAR INCISION WAS MADE AND APPROXIMATELY 2CC OF PURULENCE WAS EVACUATED FROM THE SPACE. THE AREA WAS EXPLORED AND DEBRIDED USING HEMOSTATS AND SCISSORS. THE SITE WAS THOROUGHLY IRRIGATED. THE INCISION WAS LEFT TO HEAL BY SECONDARY INTENTION. PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2025, THE SCREW ACCESS HOLE WAS UNCOVERED AND THE TEMPORARY RESTORATION WAS REMOVED. THE IMPLANT WAS REMOVED USING REVERSE TORQUE. A FULL THICKNESS FLAP WAS REFLECTED. A SMALL AMOUNT OF PURULENCE WAS EVACUATED FROM THE SITE. THE BUCCAL SPACE WAS EXPLORED USING SCISSORS. NO SIGNIFICANT PURULENCE WAS ENCOUNTERED. A PRF MEMBRANE WAS PLACED AT THE SITE. SOFT TISSUES WERE REAPPROXIMATED WITH 3-0 CHROMIC SUTURE. SITE GRAFTING AND A REPLACEMENT IMPLANT WERE ANTICIPATED IN THE FUTURE ONCE THE INFECTION HAS RESIDED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23503838 ↗
• InjuryOct 15, 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 #8 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23301791 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE #14 FELL OUT WHILE THE PATIENT WAS AT HOME DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23282216 ↗
• InjurySep 5, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22983217 ↗
• InjuryAug 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 #5 WAS REMOVED DUE TO BONE LOSS & INFECTION. (B)(6) 2025 - PERIAPICAL FILM CONFIRMS EVIDENCE OF BONE LOSS ALONG THE SURFACE OF THE IMPLANT. (B)(6) 2025 - #5- THE HEALING ABUTMENT WAS REMOVED AND THE IMPLANT WAS REMOVED USING REVERSE TORQUE. THERE WAS COMPLETE DEHISCENCE OF BUCCAL BONE NOTED AND THERE WAS APPROXIMATELY 6MM OF ROOT EXPOSURE ON #6. ALL OTHER BONY WALLS WERE NOTED TO BE INTACT. THE SITE WAS SMOOTHED, CURATED, AND IRRIGATED. DECORTICATED. AN OSSEOGUARD NON-FLEX MEMBRANE WAS PLACED OVER THE BUCCAL DEFECT. CO/CA/XE REGENEROSS BONE WAS MIXED WITH PRF EXUDATE AND USED TO GRAFT THE OSTEOTOMY. A PRF MEMBRANE WAS PLACED OVERLYING THE GRAFT. SOFT TISSUES WERE REAPPROXIMATED WITH 3-0 GUT SUTURE. SYMPTOMS AS A RESULT OF THE EVENT: REDNESS AND BUMP ON THE GUMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 22882444 ↗
• InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED INFECTION. PATIENT STATED HE NEVER GOT A CROWN ON THE IMPLANT DUE TO TRAVELLING. STATED 3 DAYS AGO HE NOTICED A LOT OF SWELLING AND PAIN, TOOTH 19.INFLAMMATION WAS A SYMPTOMS AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED. NO DELAY DURING THE PROCEDURE. ADDITIONAL APPOINTMENT WAS REQUIRED FOR BONE GRAFTING IN ONE WEEK, RE-IMPLANT IN 3 MONTHS.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22880293 ↗
• InjuryAug 1, 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 (B)(6) WAS REMOVED DUE TO INCREASING AND PROGRESSIVE PAIN AND WAS SYMPTOMATIC FOR WEEKS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 22690441 ↗
• InjuryJul 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 #19 WAS REMOVED DUE TO BONE LOSS. AT 2 MONTHS POST OP PLACEMENT OF IMPLANT #19, IMPLANT WAS NOTED MOBILE WITH SIGNIFICANT BONE LOSS. IMPLANT AND NECROTIC BONE WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 22579712 ↗
• InjuryJul 11, 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 #29 WAS REMOVED DUE TO INFECTION, SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 22484781 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #30 AND #31 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22478152 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #30 AND #31 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22478059 ↗
• InjuryJul 8, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22440833 ↗
• InjuryJun 21, 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 #20 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 22303800 ↗