3i T3® BOSS415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868028840), received between Mar 4, 2022 and Sep 28, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  Doctor reported that implant was removed due to infection. A month after implant insertion there was a massive infection. Tooth site 25.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50913529 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that the implant at tooth site 25 was removed due to bone loss and inflammation. The patient reported pain.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 50278491 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25285705 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #33 AND #43 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25190288 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #33 AND #43 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25190056 ↗
• 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23648519 ↗
• 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. PATIENT EXPERIENCING SWELLING A WEEK AFTER PLACING IMPLANTS SENT PATIENT FOR 3D AND ORAL SURGEON RECOMMENDED REMOVING IMPLANT. IMPLANT REMOVED SITE GRAFTED. WILL PLACE NEW IMPLANTS IN 6 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22065439 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITE 32.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13665547 ↗