3i T3® BOST3285Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00844868028918), received between Sep 16, 2019 and Sep 17, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 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 two implants were removed due to a bone loss. Tooth sites 22 and 27.Bone density type: I.

  Patient problems: Osteolysis

  MAUDE report 50799305 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #44 AND #41 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25303463 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #44 AND #41 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25303369 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #42-43 WAS REMOVED DUE TO BONE LOSS. DOCTOR REPORTED GUM IS IN BAD CONDITION. PATIENT EXPERIENCED PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 23629409 ↗
• InjuryJun 3, 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 BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22135118 ↗
• InjuryMay 21, 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 PERI-IMPLANTITIS. TOOTH SITE # 45.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22060456 ↗
• InjuryMay 13, 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: Unspecified Infection

  MAUDE report 22009351 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 14 WAS REMOVED DUE TO BONE LOSS CAUSED BY BIPHOSPHONATE THERAPY. DOCTOR PERFORMED PLASTIC COVERING. PATIENT HAS BEEN RESCHEDULED FOR A CHECK UP AND NEW IMPLANT PLACEMENT AFTER HEALING TIME.

  Patient problems: Osteolysis

  MAUDE report 21958845 ↗
• InjuryApr 22, 2025Adverse 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; Unspecified Infection

  MAUDE report 21880114 ↗
• InjuryApr 22, 2025Adverse 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; Unspecified Infection

  MAUDE report 21880093 ↗
• InjuryMar 3, 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. BONE TYPE II.TOOTH LOCATION 21.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21504005 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BONE LOSS ON SITE #29. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 21172746 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS VERY LOOSE AND CAME RIGHT OUT DUE TO BONE LOSS. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 20175034 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE HAD BONE LOSS, AND WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 20161353 ↗
• InjuryAug 16, 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; Unspecified Infection

  MAUDE report 19998645 ↗
• InjuryJun 21, 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 #22 HAD TO BE REMOVED AFTER THE PT CAME INTO THE OFFICE COMPLAINING OF A LOOSE IMPLANT AND IT WAS THEN DISCOVERED THAT THE PT HAD A PERI-IMPLANTITIS IN IMPLANT SITE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19584233 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED A FOCUS OF INFECTION LOCATED ON THE CREST OF THE GUM AFTER 3 WEEKS. IMPLANT WAS REMOVED. NO IMPACT ON THE PATIENT REPORTED. TOOTH LOCATION: 26.

  Patient problems: Unspecified Infection

  MAUDE report 18922579 ↗
• InjuryFeb 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 43 WAS REMOVED DUE TO PERI-IMPLANTITIS. A NEW IMPLANT WILL BE REPLACED AFTER 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18630671 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT SITE UNK WAS REMOVED DUE TO TRAUMA OF CHEWING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18560452 ↗
• InjuryJan 4, 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 14, 24 AND 26 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 18442445 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 15 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371366 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN RELEASED FOR THE IMPLANT RESTORATION. WHEN THE PATIENT WAS AT THE GENERAL DENTIST'S OFFICE, REQUESTED EXAMINATION OF THE IMPLANT ONE MORE TIME DUE TO THE X-RAY TAKEN AT THE OFFICE. THE DOCTOR EXAMINED THE IMPLANT AND THE X-RAY TAKEN BY THE PATIENT'S GENERAL DENTIST. IT WAS NOTED THAT THE IMPLANT HAD TO BE REMOVED DUE TO BONE LOSS SURROUNDING THE IMPLANT AT TOOTH SITE #20.

  Patient problems: Osteolysis

  MAUDE report 18331639 ↗
• InjuryNov 30, 2023Adverse 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 #10, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18243853 ↗
• InjuryNov 24, 2023Adverse 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: Pain; Swelling/ Edema

  MAUDE report 18204048 ↗
• InjuryAug 23, 2023Adverse 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 #5. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis

  MAUDE report 17601944 ↗