3i T3® BOST3213Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00844868028895), received between Oct 15, 2019 and Sep 18, 2026 — classified as 100 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to an infection, tooth site 4.Patient suffered from abscess, pain, inflammation and swelling.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 50815849 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 50815799 ↗
• InjuryJan 19, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107479 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT SAW GD FOR REGULAR EXAM AND THEY NOTICED HYBRID WAS LOOSE AND ONE IMPLANT FAILED. PROCEDURE COMPLETED WITH ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23967791 ↗
• InjuryNov 26, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654367 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTIC ON (B)(6) 2025 BEFORE THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22485204 ↗
• InjuryJun 14, 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 #33, #41 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22208414 ↗
• InjuryMar 28, 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 #23 WAS REMOVED DUE TO BONE LOSS. BONE LOSS AROUND IMPLANT SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 21717829 ↗
• InjuryMar 27, 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 #12 WAS REMOVED DUE TO BONE LOSS. PATIENT PRESENTED WITH RADIOGRAPHIC BONE LOSS AROUND IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 21706592 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION AT TOOTH SITE #22. IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 21631483 ↗
• InjuryFeb 11, 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. IMPLANT WAS INITIALLY PLACED IMMEDIATELY AFTER EXTRACTION OF TOOTH #10 WITH SOCKET BONE GRAFT. DETECTED MILD MODERATE PERI-IMPLANTITIS AT 6 MONTH STAGE HEALING WITH 40% BONE LOSS DESPITE INTEGRATION OF IMPLANT. ATTEMPTED TO TREAT THE IMPLANT DEFECT WITH BONE GRAFTING WITH NO SUCCESS - OPENED TO REMOVE IMPLANT AT 1 YEAR. TOOTH #10 WAS EXTRACTED AND THE IMPLANT ((B)(6)) WAS IMMEDIATELY PLACED AND RESTORED WITH A SCREW-RETAINED PROVISIONAL CROWN. #10 IMPLANT WAS FOUND TO HAVE SIGNS OF MODERATE PERI-IMPLANTITIS, INCLUDING ~6 MM LOSS OF CIRCUMFERENTIAL IMPLANT BONE AROUND THE IMPLANT PLATFORM WITH BLEEDING/EXUDATE FROM THE SULCUS. THE IMPLANT WAS STILL PARTIALLY INTEGRATED WITH NO SIGNS OF MOBILITY, SO THE PROVISIONAL CROWN WAS REMOVED, COVER SCREW PLACED, AND BONE GRAFTING WAS PLACED FOR A REGENERATIVE APPROACH. POST-TREATMENT EVALUATIONS OF THE #10 IMPLANT SITE SHOWED NO EVIDENCE OF SUFFICIENT REGENERATION OF THE PERI-IMPLANT DEFECT, WITH PERSISTENT AND PROGRESSIVE MOBILITY OF ADJACENT TEETH #9 AND 11. OPTED FOR REMOVAL OF THE #10 IMPLANT WITH PLACEMENT OF A SOCKET BONE GRAFT TO STABILIZE THE #9-11 SITE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21357842 ↗
• InjuryFeb 11, 2025Adverse 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; Unspecified Infection

  MAUDE report 21356717 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #42. PATIENT WENT TO DENTIST OFFICE WITH PAIN AND GRADE III MOBILITY . ADDITIONAL APPOINTMENT REQUIRED TO PLACE A NEW IMPLANT BUT NOT SCHEDULED YET.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21157169 ↗
• InjuryJan 13, 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 #10 WAS REMOVED DUE TO BONE LOSS. ESTHETIC CONCERNS.

  Patient problems: Osteolysis

  MAUDE report 21144142 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 33, 43 WERE REMOVED DUE TO PER-IMPLANTITIS WITH INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21065638 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED UNCOVERED IMPLANT. IMPLANT HAD INFECTION & DID NOT INTEGRATE. INDICATED IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO, PATIENT WILL HAVE A BRIDGE. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20566688 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 13 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20426675 ↗
• InjuryAug 28, 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 20088993 ↗
• InjuryAug 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 31 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19999052 ↗
• InjuryAug 18, 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 #20 WAS REMOVED DUE TO BONE LOSS. PATIENT WAS IN PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 19998915 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE # 27 WAS REMOVED DUE TO INFECTION. NOTED INFLAMMATION AND THE SITE WAS GRAFTED WITH ALLOGRAFT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19933163 ↗
• InjuryAug 7, 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 INFECTION. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19929350 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 21 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19926716 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A SIGNIFICANT INFECTION OF THE IMPLANT SITE. REQUIRING I AND D AND REMOVAL OF IMPLANT. TOOTH #27. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 19704751 ↗
• InjuryJun 28, 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 #24 WAS REMOVED DUE TO INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS BEFORE STARTING THE PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19635750 ↗