3i T3® BOST611Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00844868029717), received between Dec 11, 2019 and Feb 6, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Osteolysis

  MAUDE report 24277812 ↗
• InjuryMar 19, 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 #30 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 21645654 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #14 FAILED TO INTEGRATE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19120323 ↗
• InjuryApr 12, 2024Adverse 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 #3 SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19101768 ↗
• InjuryJan 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: Osteolysis; Unspecified Infection

  MAUDE report 18504814 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN REPORTED PATIENT COMPLAINING IMPLANT CAUSING PAIN AND BECAME LOOSE. SITE WAS GRAFTED WHEN IMPLANT WAS PLACE WITH ALLOGRAFT. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17289592 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN REPORTED PATIENT COMPLAINING SITE 3 IMPLANT WAS CAUSING PAIN AND BECAME LOOSE. NOTED PERI-IMPLANTITIS. NO FURTHER IMPACT TO PATIENT. SITE GRAFTED WITH ALLOGRAFT DURING IMPLANT PLACEMENT. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17288237 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #19 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16665789 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT IS TO RETURN FOR REMOVAL OF IMPLANT AND GRAFTING. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 15485702 ↗
• InjurySep 8, 2022Adverse 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 THE PATIENT NOTING NUMBNESS AND NERVE INJURY.

  Patient problems: Nerve Damage; Numbness; Paresthesia

  MAUDE report 15385703 ↗
• InjuryAug 9, 2022Adverse 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 INFECTION OBSERVED AT UNCOVERY AT THE IMPLANT SITE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15191256 ↗
• InjuryApr 21, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR INDICATED PERI-IMPLANTITIS, LOSS OF INTEGRATION, INFECTION, BONE LOSS AND PAIN ON CHEWING. THE IMPLANT WAS REMOVED AND THE PATIENT WILL RETURN AFTER HEALING. TOOTH SITE # 36.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 14167522 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT TOOTH SITE #30 AND IMPLANT WAS REMOVED. PATIENT'S CONDITION AT THE TIME OF EVENT: HEALTHY. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, ABSCESS & PAIN.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 10044255 ↗
• InjuryApr 15, 2020Adverse 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: Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 9962650 ↗
• InjuryJan 15, 2020Adverse 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 INFECTION. THE PATIENT ALSO PRESENTED ABSCESS, EDEMA, AND INFLAMMATION. TOOTH LOCATION 11.

  Patient problems: Unspecified Infection

  MAUDE report 9592254 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS INFECTION AROUND IMPLANT BOST611. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9494678 ↗
• InjuryDec 11, 2019Adverse 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 AT SITE LOCATION 3. EDEMA, INFLAMMATION, BAD TASTE AND SMELL WAS ALSO REPORTED. SITE WAS BONE GRAFTED.

  Patient problems: Edema; Inflammation; Unspecified Infection

  MAUDE report 9454084 ↗