3i T3® BOSS411Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00844868028826), received between Mar 23, 2020 and Aug 18, 2026 — classified as 36 injuries.

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 36 reports, in the reporter's own words as published by the FDA.

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

  The doctor reported that the implant at site 36 was removed due to bone loss, infection, and inflammation.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50295156 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23702679 ↗
• InjuryNov 17, 2025Fracture; Fracture

  THE IMPLANT'S HEAD FRACTURED AFTER 2 YEARS IN MOUTH AND THE IMPLANT AT TOOTH SITE 16 WAS REMOVED. SWELLING AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23567246 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A CHECK UP AND THE IMPLANT AT TOOTH SITE #5 WAS FOUND TO BE INFECTED. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 23015145 ↗
• InjurySep 10, 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 #5 FELL OUT ON IT'S OWN DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23015041 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #33 DETECTED WHILE LOADING THE IMPLANT. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22225343 ↗
• 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 # 46.

  Patient problems: Unspecified Infection

  MAUDE report 22060404 ↗
• InjuryApr 24, 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 PERI-IMPLANTITIS WITH INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21897916 ↗
• InjuryNov 21, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20754012 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE IMPLANT AT TOOTH #34 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20460358 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #32 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19622708 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19612661 ↗
• InjuryMay 16, 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 #14 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19331022 ↗
• InjuryMar 21, 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 PERI-IMPLANTITIS. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT. PERI-IMPLANT BONE FRACTURE WAS ALSO REPORTED.

  Patient problems: Bone Fracture(s); Osteolysis; Unspecified Infection

  MAUDE report 18948043 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN. IMPLANT WAS REMOVED WITH TWEEZERS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18638718 ↗
• InjuryJan 4, 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 45 WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 18446902 ↗
• InjuryDec 28, 2023Adverse 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. BRUXISMUS IN COMBINATION WITH INFECTION. PATIENT HAS BEEN RESCHEDULED FOR AUGMENTATION AND NEW IMPLANT PLACEMENT.

  Patient problems: Inflammation

  MAUDE report 18410629 ↗
• InjuryNov 7, 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: Bone Fracture(s)

  MAUDE report 18088604 ↗
• InjuryOct 23, 2023Fracture; Fracture

  DOCTOR REPORTED IMPLANT FRACTURE WITH PAIN AT TOOTH SITE 37.

  Patient problems: Pain

  MAUDE report 17983019 ↗
• InjuryAug 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 #8 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 17585500 ↗
• InjuryNov 23, 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15851507 ↗
• InjurySep 7, 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 AT THE SITE. PATIENT WILL RETURN FOR AN ADDITIONAL APPOINTMENT IN THE FUTURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15371415 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH 26 WAS REMOVED DUE TO BONE LOSS AND SINUS PAIN. DISCOMFORT AND EDEMA WERE ALSO REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED.

  Patient problems: Discomfort; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15303966 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI-IMPLANTITIS WAS REPORTED, IMPLANT PRESENTED WITH SEVERE BONE LOSS, SWELLING, PURULENCE. IMPLANT IN TOOTH SITE #27 FELL OUT. ABSCESS AND PAIN ARE REPORTED AS SYMPTOMS. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Abscess; Osteolysis; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 15182697 ↗
• InjuryAug 3, 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 WITH AN ABSCESS AT THE SITE.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 15156398 ↗