3i T3® BOPT5485Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00844868028529), received between Nov 6, 2019 and May 29, 2026 — classified as 93 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 94 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED LOOSENING OF SCREW AND PROSTHETIC AT TOOTH SITES 15 AND 16, WHAT RESULTED IN A MASSIVE INFLAMMATION AND BONE LOSS. DOCTOR ALSO INDICATED INFECTION AND EDEMA. IMPLANTS REMAIN IMPLANTED. PATIENT REFERRED PAIN. PATIENT HAS BEEN RESCHEDULED FOR NEW PROSTHESIS AND SCREWS. SCREWS PLACEMENT DATE (B)(6) 2023 AND REMOVAL DATE: (B)(6) 2026. THIS REPORT REFERS TO ONE OF THE BONE LOSS AND INFECTION EVENTS.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 25328794 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24845134 ↗
• MalfunctionFeb 27, 2026Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474640 ↗
• InjuryDec 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO DAMAGED HEXAGON. IT WAS IMPOSSIBLE TO REMOVE THE PROSTHETIC ABUTMENT FROM THE IMPLANT FOLLOWING THE DETACHMENT OF THE SCREW-RETAINED CROWN AND THE TIBASE. PROCEDURE WAS NOT COMPLETED. BONE DENSITY TYPE: II.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693023 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #46. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22224919 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #16. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22201572 ↗
• InjuryMay 28, 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 BONE LOSS CAUSED BY PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22102529 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING LOTS OF PAIN AND SINUS ISSUES. THE DOCTOR AND PATIENT THOUGHT IT WAS BEST TO HAVE THE IMPLANT AT TOOTH SITE #3 REMOVED DUE TO PERI-IMPLANTITIS & SINUS PERFORATION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS; INFLAMMATION; PAIN & SWELLING.

  Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection

  MAUDE report 22009176 ↗
• InjuryApr 24, 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 #11 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21898595 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 26 WAS REMOVED DUE TO PERI IMPLANTITIS. INFLAMMATION REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21196909 ↗
• InjuryJan 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 #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21196208 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT CHECK WAS BEING PERFORMED AND THE IMPLANT AT TOOTH LOCATION #3 WAS FOUND TO BE MOBILE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20819280 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO INFECTION. PATIENT PRESENTS FOR POST-OP CHECK WITH DISCHARGE FISTULA #14 AREA. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 20637310 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 16 LOOSENED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. LOOSENING THROUGH TELESCOPIC RESTAURATION. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20631030 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI-IMPLANTITIS WAS REPORTED AT TOOTH SITE 26 AND THE IMPLANT WAS REMOVED. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20565018 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #47 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20564951 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #16/26 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20564721 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #16/26 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20564637 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20544008 ↗
• InjuryOct 2, 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 #UNK WAS REMOVED DUE TO INFECTION. PATIENT HAD THE COMPLAINT OF PAIN / DISCOMFORT SINCE IMPLANT PLACEMENT ON (B)(6) 2024. PATIENT WAS PRESENT IN THE OFFICE ON (B)(6) 2024 WHERE THE IMPLANT WAS REMOVED DUE TO ACTIVE INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 20355224 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6)2025 SMW SUBMITTED FOR INVESTIGATION RESULTS. (B)(6).

  Patient problems: Osteolysis

  MAUDE report 20260193 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 20260028 ↗
• InjurySep 17, 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; Pain

  MAUDE report 20240322 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964742 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964199 ↗