3i T3® BOST413Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00844868028949), received between Nov 14, 2019 and Aug 22, 2026 — classified as 135 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 137 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to Peri-implantitis. No patient impact. Tooth site 11.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50388045 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. DEHISCENCE, INFLAMMATION AND PURULENCE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25280862 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR INDICATED THE IMPLANT AT TOOTH SITE #34 WAS REMOVED DUE TO INFECTION. DURING HEALING IMPLANT SHOWED SIGNS OF CHRONIC INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 24647773 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SUTURE REMOVAL APPOINTMENT, THE IMPLANT AT TOOTH SITE #7 HAD SWELLING AND PAIN. THE IMPLANT HAD TO BE REMOVED DUE TO INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24257098 ↗
• InjuryAug 7, 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 INFECTION. TOOTH SITE #14. INFLAMMATION AFTER IMPLANTATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22736553 ↗
• InjuryJul 11, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478580 ↗
• InjuryJul 11, 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. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478529 ↗
• InjuryJul 11, 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 #25 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478404 ↗
• InjuryJul 11, 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 PERI-IMPLANTITIS. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478389 ↗
• InjuryJul 11, 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 #20 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478112 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #22-24. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANTS WERE REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22218037 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE # 22-24. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANTS WERE REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22217783 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #33. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22217731 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITES #32 - #42. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. BOTH IMPLANTS WERE REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22209565 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITES #32 - #42. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. BOTH IMPLANTS WERE REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22209541 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #44. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22209435 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #45. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22209280 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #25. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22201417 ↗
• InjuryJun 3, 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 #6 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22134140 ↗
• InjuryMay 30, 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 #9 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22118754 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISCOMFORT AND MOBILITY AROUND THE IMPLANT AT TOOTH SITE #6. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21980111 ↗
• InjuryMar 27, 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 #23 FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21708507 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AND THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21707031 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #21 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21195747 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21195606 ↗