T3 T3ST3213Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00844868046882), received between Sep 14, 2023 and Aug 18, 2026 — classified as 36 injuries.

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 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  The patient presented for second-stage treatment on (b)(6) 2026 with a large abscess and bone loss around the implant at site #24. The implant was removed, and a bone graft was placed.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50298561 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 LOOSENED AND WAS REMOVED DUE TO BONE LOSS & INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24599022 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED DUE TO INFECTION. AN ADDITIONAL PROCEDURE WAS ANTICIPATED TO REPLACE THE IMPLANT APPROXIMATELY THREE OR FOUR MONTHS LATER AS THE SITE HEALED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24575078 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #23 AND #25 FAILED THE TORQUE TEST AND WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24290272 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #23 AND #25 FAILED THE TORQUE TEST AND WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24290256 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23950604 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT DID NOT TAKE HER ABX IMPLANT LOST TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION. TOOTH SITE: 7.

  Patient problems: Unspecified Infection

  MAUDE report 23839065 ↗
• InjuryNov 6, 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. THE PATIENT PRESENTED TO UNCOVER THE IMPLANT. IMAGING CONFIRMED RADIOLUCENCY AT THE APICAL FOR APPROXIMATELY 1/3 OF THE IMPLANT. AN ADDITIONAL APPOINTMENT WAS REQUIRED, BUT NO INFORMATION WAS PROVIDED TO CLARIFY THE DETAILS OF THIS APPOINTMENT.

  Patient problems: Unspecified Infection

  MAUDE report 23489861 ↗
• InjuryNov 5, 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: Pain; Unspecified Infection

  MAUDE report 23480196 ↗
• InjuryAug 19, 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 DENTAL POSITION NUMBER #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22839822 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SYSTEMATIC OFFICE VISIT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO INFECTION ASSOCIATED WITH PERI-IMPLANTITIS. TH ADJACENT TEETH BECAME INFECTED AND COMPROMISED THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22566518 ↗
• InjuryJul 17, 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: Erosion; Unspecified Infection

  MAUDE report 22530339 ↗
• 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 #24 WAS REMOVED DUE TO INFECTION. PATIENT PRESENTED 9 DAY POST OP APPOINTMENT, THE PATIENT STATED HE MAY AN INFECTION. THERE IS A BUBBLE RIGHT WHERE THE IMPLANT IS. THE PATIENT WAS GIVEN A PRESCRIPTION FOR AUGMENT FOR 1 WEEK. THE PATIENT RETURNED 4 DAYS LATER STATING THE IMPLANT SITE IS STILL FEELS THE SAME; LINGUAL SWELLING & LABIAL FISTULA NOTED. LABIAL INCISION & DRAINAGE WAS DONE, TINY BONE FRAGMENTS WERE REMOVED & IRRIGATED. PATIENT RETURNED TO THE OFFICE 4 DAYS LATER; PATIENT STATED IT FEEL BETTER. PATIENT RETURNED 1 WEEK LATER; IMPLANT RE-INFECTED& MOBILE; IMPLANT WAS REMOVED & DEBRIDED SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22530281 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO A NINE (9) DAY POST OP APPOINTMENT STATING THAT "THERE IS A BUBBLE RIGHT WHERE THE IMPLANT IS " INDICATING THAT IT MAY BE AN INFECTION AROUND THE IMPLANT AT TOOTH LOCATION #24. THE PATIENT WAS GIVEN A PRESCRIPTION FOR AUGMENT FOR ONE WEEK DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 22529687 ↗
• InjuryJul 16, 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 #UNK WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT DO NOT INTEGRATED, BONE LOSS, INFLAMMATION SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22521603 ↗
• InjuryMay 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 #28 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22073004 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #23 FAILED AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21514429 ↗
• InjuryFeb 3, 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: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 21298006 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH NUMBER: 10 SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21095994 ↗
• InjuryDec 7, 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 #10 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 20873574 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 REPORTED CONFIRMED NO ANTIBIOTICS WERE PRESCRIBED TO PATIENT. IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO INFECTION. INFECTION IMPLANT #10 PUS. PATIENT DID NOT TAKE ANTIBIOTICS; PATIENT HAD A PURULENCE AND CYST ON # 8 AND 9. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVED AND BONE GRAFT. ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION.

  Patient problems: Unspecified Infection

  MAUDE report 20619938 ↗
• InjuryOct 7, 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 #27 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 20389419 ↗
• InjuryAug 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE DUE TO ALLERGIC REACTION AND WAS REMOVED. PROCEDURE NOT COMPLETED AFFECTED DENTAL POSITIONS: #34 AND #44.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20062965 ↗
• InjuryAug 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE DUE TO ALLERGIC REACTION AND WAS REMOVED. PROCEDURE NOT COMPLETED AFFECTED DENTAL POSITIONS: #34 AND #44.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20062938 ↗
• InjuryAug 22, 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 #24 WAS REMOVED DUE TO INFECTION. DISCOVERED PURULENT DRAINAGE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION & PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20034871 ↗