3i T3® BOSS510Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868029557), received between Jun 18, 2020 and Dec 19, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 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 # 46 WAS REMOVED DUE TO AN INFECTION. PATIENT HAD ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23854157 ↗
• InjurySep 15, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, ABSCESS AND INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 23056152 ↗
• InjuryAug 19, 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 19999607 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS WITH FISTULA AND INFLAMMATION AT TOOTH SITE 46. DOCTOR PERFORMED REMOVAL OF IMPLANT, CURETTAGE AND STITCHING AND PRESCRIBED NEOMYCIN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17899169 ↗
• InjuryMay 5, 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: Abscess; Unspecified Infection

  MAUDE report 16875952 ↗
• InjuryMar 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 30 WAS REMOVED DUE TO FRACTURE AT IMPLANT COLLAR. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT. PATIENT CAME TO CLINICS WITH LOOSENING CROWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pseudoaneurysm

  MAUDE report 16579855 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15315769 ↗
• InjuryMay 26, 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 AT THE IMPLANT SITE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14519402 ↗
• InjuryMay 6, 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 PERI-IMPLANTITIS. INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 14304455 ↗
• InjuryDec 16, 2021Adverse 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 13019164 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LACK OF PRIMARY STABILITY AT SITE #8. IMPLANT REMOVED DUE TO LOSS OF INITIAL STABILITY. PATIENT RETURNING FOR BONE GRAFT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301743 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 28 WAS UNABLE TO PLACE IN OSTEOTOMY, LACK OF PRIMARY STABILITY AT THE IMPLANT SITE AND WAS NEVER PLACED PER INDICATED: NO INITIAL STABILITY, DID BONE GRAFT . SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO INJURY TO PATIENT OTHER THAN IMPLANT BEING REMOVED. NO PERMANENT IMPAIRMENT. ADDITIONAL APPOINTMENT REQUIRED: NO, NOTHING REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.

  Patient problems: No Information

  MAUDE report 10975776 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10166959 ↗