3i T3® BOPT4385Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00844868028499), received between Nov 13, 2019 and May 27, 2026 — classified as 49 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO BONE LOSS. NO IMPACT ON THE PATIENT WAS REPORTED.

  Patient problems: Osteolysis

  MAUDE report 25306363 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25231093 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25191064 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #24 AND #25 WERE REMOVED AFTER THE PROSTHETIC RESTORATION DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24835183 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 35 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24606688 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE # 25.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23380867 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED ANTIBIOTICS DUE TO INFECTION AND PAIN AT TOOTH SITE #4. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22890710 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED AND SAID THAT THE IMPLANT AT TOOTH SITE #4 WAS LOOSE AND KILLING THEM. THE IMPLANT WAS REMOVED DUE TO PAIN AND INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22889016 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 33 WAS REMOVED DUE TO PERI-IMPLANTITIS AND OSTEOCHEMONECROSIS. EDEMA AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Necrosis; Osteolysis; Unspecified Infection

  MAUDE report 21983013 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT THE IMPLANT AT TOOTH LOCATION #25 (FDI) FEELS MOBILE AND THE GUM TISSUE HAS OVERGROWN. FIBROUS ENCAPSULATION WAS ALSO REPORTED. IT WAS NOTED THAT THE PATIENT MAY HAVE CHEWED ON SOMETHING HARD. THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935682 ↗
• InjuryApr 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT PATIENT HAD TITANIUM ALLERGY, FAILED 3 MON AFTER PLACEMENT. TOOTH 4. IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED FOR RIDGE AUGMENTATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21805957 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS ONE YEAR AFTER THE IMPLANTATION AT TOOTH SITE 26 OBSERVED DURING THE CLINICAL PROCEDURE AND THE IMPLANT WAS REMOVED. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. BONE GRAFT WAS PERFORMED. THE PROCESS WILL BE COMPLETED WITH ANOTHER IMPLANT (WHEN REGENERATION OCCURS) AN ADDITIONAL APPOINTMENT WAS REQUIRED TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21707548 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21619197 ↗
• InjuryMar 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 #19 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT; ABSCESS AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 21577009 ↗
• InjuryMar 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 #18 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT; ABSCESS AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 21575609 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS DISCOVERED DURING 2ND SURGERY A LOST OF INTEGRATION DUE TO A PERIIMPLANTITIS AT TOOTH SITE #23. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21469753 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #46. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20793930 ↗
• 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 20256737 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANTS AT TOOTH #36/46 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20254788 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461145 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 36 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19097822 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 36 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19097669 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #27, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18918675 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT SITE #20 HAD GRANULATED TISSUE PRESENT, BONE LOSS AND NO STABILITY. THE IMPLANT WAS REMOVED. SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO AND WITH IMPLANT PLACEMENT. HAS A HISTORY OF OSTEOPOROSIS. NOTED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18807474 ↗
• InjuryJan 26, 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 #18 WAS REMOVED DUE TO INFECTION. HALO AROUND IMPLANT. IMPLANT WAS ACCIDENTALLY THROWN AWAY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Unspecified Infection

  MAUDE report 18586448 ↗