3i T3® DCD® BNPT6511Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868029519), received between Aug 14, 2020 and Sep 28, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #30, WITH ASSOCIATED PAIN AND INFLAMMATION. THE IMPLANT/CROWN ALL BECAME LOOSE AND EVENTUALLY THE IMPLANT LOST ITS INTEGRATION AND WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17833804 ↗
• InjuryJul 31, 2023Adverse 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17423869 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 12, 13, AND 14 WERE REMOVED DUE TO INFECTION. NOTED PATIENT HAD POST NASAL DRIP AND CONGESTION. SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: POST NASAL DRIP, CONGESTION AND INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15380349 ↗
• InjuryDec 9, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO ALLERGIC REACTION. DISCOMFORT AFTER HEALING, PATIENT REQUESTED REMOVAL. PAIN WAS REPORTED. PATIENT WILL RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH# 15.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 12972994 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SITE GRAFTED. ADDITIONAL APPOINTMENTS IMPLANT RE-PLACEMENT: NOT INDICATED. SYMPTOMS AS A RESULT OF THE EVENT: PERI-IMPLANTITIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10480733 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BNPT6511) WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION 14. SITE WAS BONE GRAFTED. INFLAMMATION, BONE LOSS WERE ALSO NOTED.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10408794 ↗