3i T3® BOST610Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00844868029700), received between Dec 19, 2019 and Jun 8, 2026 — classified as 44 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS SURROUNDING THE RESTORED IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 25436138 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE HAD BONE LOSS SURROUNDING RESTORED IMPLANT DISCOVERED DURING ROUTINE CLEANING. IMPLANT REMOVED WITH SITE DEBRIDEMENT. WILL REPLACE AFTER 4 MONTHS OF HEALING.

  Patient problems: Osteolysis

  MAUDE report 25430525 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection

  MAUDE report 24298791 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain

  MAUDE report 24246369 ↗
• InjuryJun 12, 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. DURING SURGERY FOR DIEM, BONE LOSS WAS NOTED SURROUNDING EXISTING IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 22197917 ↗
• InjuryJan 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 #19 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 21184442 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANT AT TOOTH NUMBER 31 HAD TO BE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 20408270 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SURGICAL REMOVAL OF IMPLANT DUE TO BONE LOSS. TOOTH NUMBER # 30.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20040259 ↗
• InjuryJul 24, 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 # 2 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19818867 ↗
• InjuryJul 22, 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19799005 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICIAN, IN (B)(6) 2023, SURGICALLY REOPENED THE IMPLANT SITE AND PERFORMED A LASER-ASSISTED DISINFECTION/DEBRIDEMENT OF THE IMPLANT SURFACE. AT THIS TIME I CAUTIONED THE PATIENT THAT THE IMPLANT HAD A HIGH RISK FOR FAILURE. TOOTH SITE #19 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19633873 ↗
• InjuryJun 28, 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 SITE #19 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19633297 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN PATIENT PRESENTED FOR SECOND STAGE EXPOSURE SURGERY, WE DIAGNOSED WITH A LOCALIZED ADVANCED PERI-IMPLANTITIS DEFECT CHARACTERIZED BY GINGIVAL INFLAMMATION, EXUDATE TO PROBING WITH A 8-9MM PROBING DEPTH AND A SMALL SEQUESTRUM OF NECROTIC BONE ATTACHED TO THE IMPLANT SURFACE. THE CLINICIAN SURGICALLY EXPOSED THE IMPLANT, REMOVED THE NECROTIC BONE, TESTED THE IMPLANT FOR OSSEOINTEGRATION (PASSED TORQUE TEST AT 20 N/CM) AND RESCHEDULED THE PATIENT FOR RE-EVALUATION. SITE # 19 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19633096 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT PRESENTED WITH MOBILE CROWN/IMPLANT PA REVIEWS BONE LOSS AROUND IMPLANT. SITE WAS DEBRIDE, BONE GRAFT PLACED, WILL RE-EVALUATE HER IN 3 MONTHS. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18377718 ↗
• InjuryDec 21, 2023Adverse 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 WAS REMOVED DUE TO ACUTE INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 18374590 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT EXPOSED, NOT BONE ON FACIAL. TOOTH #23. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18176024 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS NOTED SURROUNDING RESTORED IMPLANT #2. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis

  MAUDE report 18088148 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERIIMPLANTITIS AT IMPLANT TOOTH SITE #3, WITH ASSOCIATED PAIN AND INFLAMMATION. THE IMPLANT CAME OUT AND THE PATIENT PRESENTED TO GENERAL DENTIST WITH IMPLANT AND RESTORATION IN HAND. THE IMPLANT WAS INITIALLY RESTORED WITH CUSTOM BELLATEK ABUTMENT AND CROWN; BUT THEN IT LOST INTEGRATION AND WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17742519 ↗
• InjuryJul 18, 2023Adverse 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; Osteolysis; Pain

  MAUDE report 17343188 ↗
• InjuryJul 18, 2023Adverse 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; Osteolysis; Pain

  MAUDE report 17342939 ↗
• InjuryFeb 3, 2023Adverse 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 16295411 ↗
• InjuryJan 26, 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 SURROUNDING THE IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 16248552 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CHRONIC INFECTION AT TOOTH SITE # 30. THE IMPLANT WAS REMOVED, AND SITE GRAFTED. THE PATIENT MAY RETURN FOR A REVISION. SYMPTOMS: PAIN, INFLAMMATION AND EDEMA.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15742771 ↗
• MalfunctionOct 17, 2022Mechanical Problem; Mechanical Problem

  DOCTOR INDICATED FIXTURE NOT ABLE TO BE FULLY TORQUED, SOMETHING WRONG WITH THE HEX, NEW FIXTURE WAS PLACED. TOOTH #47 FDI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614725 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE POST OPERATIVE APPOINTMENT, PURULENCE WAS NOTED AT THE IMPLANT AT TOOTH LOCATION #3. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 15390553 ↗