3i T3® BOST485Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00844868028963), received between Dec 3, 2019 and Jul 28, 2026 — classified as 90 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at Tooth Site 26 was removed due to peri-implantitis. The patient also reported pain.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50055093 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25303199 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24801581 ↗
• InjuryJan 15, 2026Adverse 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: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24083687 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 34 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT HAS BEEN RESCHEDULED FOR STITCHES AND A CHECK-UP.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23736181 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23659592 ↗
• InjuryNov 26, 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. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23659352 ↗
• InjuryNov 26, 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 #27 WAS REMOVED DUE TO EXTREME LOOSENING AND PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23655973 ↗
• InjuryNov 25, 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 AND MOBILITY. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23648995 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LOSS INTEGRATION DUE TO PERI-IMPLANTITIS. TOOTH SITE #26. IMPLANT WAS COMPLETELY REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23415915 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFLAMMATORY COMPLICATION IN REGION 36 OF THE IMPLANT CAUSED PAIN AND INFLAMMATION. DESPITE MEDICAL TREATMENT, THERE WAS NO IMPROVEMENT, SO THE IMPLANT HAD TO BE SURGICALLY REMOVED. IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 23082110 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #26 FAILED DUE TO INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 23049003 ↗
• InjuryAug 21, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861445 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO PERI-IMPLANTITIS DURING A CLINIC CHECK UP WITH X-RAY. PATIENT HAS BEEN RESCHEDULED FOR A FOLLOW-UP CHECK UP. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22330152 ↗
• InjuryMay 21, 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. TOOTH SITE # 34. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22066868 ↗
• 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 INFECTION. TOOTH SITE # 26. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22060257 ↗
• InjuryMay 20, 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 #36 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22051966 ↗
• InjuryMay 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 #37 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22046502 ↗
• 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. PATIENT HAS BEEN SCHEDULED FOR NEW IMPLANT PLACEMENT IN 3 MONTHS.

  Patient problems: Osteolysis

  MAUDE report 21958893 ↗
• 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 #19 WAS REMOVED DUE TO BONE LOSS. PATIENT PRESENTED WITH CIRCUMFERENTIAL BONE LOSS, IMPLANT REMOVED & SITE GRAFTED.

  Patient problems: Osteolysis

  MAUDE report 21718051 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PATIENT CAME TO FOLLOW UP ON IMPLANTS, INFECTION OF THE GINGIVAL TISSUE WAS FOUND AROUND THE IMPLANT AT TOOTH LOCATION #31. ON CLEANING OFF THE INFECTION, THE IMPLANT WAS LOOSE AND HAD BONE LOSS AROUND IT. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21713293 ↗
• InjuryDec 14, 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20932577 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION ALONG WITH BONE LOSS AT TOOTH SITE 46 OBSERVED DURING CLINICAL PROCEDURE. ONE MONTH AFTER THE IMPLANTATION DATE, DURING A ROUTINE RADIOGRAPHIC CONTROL IT WAS DETECTED BONE LOSS AROUND THE IMPLANT. ABCESS, EDEMA AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20794020 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #15 FAILED DUE TO INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 20641371 ↗
• InjuryNov 8, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638956 ↗