3i T3® BOPT5410Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 00844868028505), received between Sep 6, 2019 and Aug 22, 2026 — classified as 183 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 189 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to Peri-implantitis. No patient impact. Tooth site 27.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50388724 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a peri-implantitis. Tooth site 45. Patient suffered from pain.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50065803 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED LOOSENING OF BOTH GOLD SCREWS AT TOOTH SITES 46 AND 47 AT THE SCREWED IMPLANTS. THEY SEEMED TO HAVE FAILED OR TO HAVE BEEN LOOSE. DOCTOR ALSO INDICATED INFECTION AND INFLAMMATION, IT WAS TREATED AND IMPLANTS REMAIN IMPLANTED. PATIENT REFERRED PAIN. PATIENT HAS BEEN RESCHEDULED FOR NEW PROSTHESIS AND SCREWS. THIS COMPLAINT REFERS TO THE INFECTION IN THE SITE.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 24660437 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK WITH BONE LOSS PRESENT AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT LOST INTEGRATION AND WAS REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24208512 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED UPDATING THE CATALOG AND LOT NUMBER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23990643 ↗
• InjuryDec 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 #4 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23871535 ↗
• InjuryDec 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 #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: SINUSITIS.

  Patient problems: Unspecified Infection

  MAUDE report 23826705 ↗
• InjuryNov 18, 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: Inflammation; Osteolysis

  MAUDE report 23582307 ↗
• InjuryNov 17, 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: Osteolysis; Sinus Perforation

  MAUDE report 23574016 ↗
• InjuryOct 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 #31 WAS REMOVED DUE TO INFECTION. IMPLANT #31 DID NOT INTEGRATE NOR HEALING ABUTMENT. IT WAS TENDER ON PERCUSSION. REMOVAL & BONE GRAFT THE AREA.

  Patient problems: Unspecified Infection

  MAUDE report 23352167 ↗
• 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 22218464 ↗
• InjuryJun 13, 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 AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22205736 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE INTEGRATION CHECK, THERE WAS SUPPURATION AND BONE LOSS TO THE APICAL THIRD OF THE IMPLANT AT TOOTH SITE #36. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22167662 ↗
• InjuryMay 23, 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 BONE LOSS AND INFECTION. TOOTH SITE: 30. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 22077986 ↗
• InjuryMay 20, 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 BONE LOSS. TOOTH SITE # 26.

  Patient problems: Osteolysis

  MAUDE report 22056260 ↗
• InjuryMay 18, 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, EDEMA, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22041331 ↗
• InjuryApr 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 #20 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 21857320 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A BONE LOSS AT TOOTH SITE # 27. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 21856478 ↗
• InjuryMar 28, 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 PERIIMPLANTITIS. PAIN, NON-INTEGRATION. TOOTH #3. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21724160 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 16 WAS REMOVED DUE TO BONE LOSS WITH INFLAMMATION. WHEN PERFORMING SECOND STAGE DOCTOR NOTICED BONE LOSS AND REMOVED IT.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 21502753 ↗
• InjuryFeb 4, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21305130 ↗
• 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 #26 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21195893 ↗
• 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 #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21195540 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 15 WAS REMOVED DUE TO INFECTION. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 20923706 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 18 AND 19 WERE REMOVED DUE TO BONE LOSS. IMPLANTS PLACED ON (B)(6) 2024 WITH HEALING DENTURES. RETURNED (B)(6) 2024 FOR TORQUE TEST AND SEVERE BONE LOSS NOTED, 50% IMPLANT EXPOSURE FROM MID IMPLANT, SUPERIORLY. IMPLANTS REMOVED AND SITE GRAFTED. ADDITIONAL APPOINTMENT IS REQUIRED TO REPLACE IMPLANTS.

  Patient problems: Osteolysis

  MAUDE report 20923200 ↗