3i T3® BOSS413Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00844868028833), received between Sep 20, 2019 and Aug 18, 2026 — classified as 18 injuries.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

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

  Doctor reported that implant was removed due to bone loss and infection.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50294765 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN SINCE IMPLANT PLACEMENT AT TOOTH SITE #9. SUPPURATION WAS NOTED AND AT (B)(6), THE IMPLANT CAME OUT WITH EASE WHEN THE DRIVER WAS APPLIED TO THE COVER SCREW. SITE AUGMENTATION WAS PERFORMED AT REMOVAL AND CBCT MEDICATED. SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION, ABSCESS, EDEMA, INFLAMMATION AND PAIN.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22784879 ↗
• InjuryJul 30, 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 #32. SYMPTOMS REPORTED ON THE PATIENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22662760 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983064 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21511382 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection

  MAUDE report 21507089 ↗
• InjuryJul 12, 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 #5 HAD INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19732694 ↗
• InjuryApr 15, 2024Adverse 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 PERI-IMPLANTITIS WITH INFLAMMATION. DURING UNCOVERING DOCTOR NOTICED A FISTULA. A NEW IMPLANT AT TOOTH SITE 15 WAS PLACED.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 19110468 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOCATED IN DENTAL POSITION NUMBER #14 FAILED DUE TO INFECTION. THE DOCTOR REPORTS THAT THE INFECTION IS VISIBLE IN THE X-RAY HE HAS TAKEN. (WHICH HAS NOT BEEN SENT). BONE TYPE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19041754 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH SITE 43.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17994555 ↗
• InjuryFeb 3, 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 INFECTION AND BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16295780 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. BUCCAL FISTULA AND IMPLANT MOBILITY DISCOVERED AT TIME FOR CROWN ATTACHMENT. PATIENT WILL REQUIRE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 15436057 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE BOSS413 IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580909 ↗
• 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 10976330 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BOSS413) WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT LACK OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 6.

  Patient problems: No Information

  MAUDE report 10608534 ↗
• InjuryMar 11, 2020Adverse 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: Unspecified Infection

  MAUDE report 9816846 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT BOSS413 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9487315 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #5 COULD NOT BE PLACED DUE TO A LACK OF PRIMARY STABILITY. AUGMENTATION WAS PERFORMED AND THE SITE WAS LEFT FOR HEALING. THERE WAS A REPORTED 30 MINUTE DELAY IN PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9097846 ↗