3i T3® DCD® BNST511Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868029304), received between Sep 17, 2019 and Mar 6, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 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 AN UNKNOWN POSITION FAILED BECAUSE OF AN INFECTION AND WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN, SWELLING, AND BLEEDING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 21535652 ↗
• InjuryMar 6, 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 POSITION NUMBER #36 FAILED BECAUSE OF AN INFECTION, IMPLANT WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 21535225 ↗
• InjuryJan 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 # 4 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 21277097 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR SAW THIS PATIENT IN SEPTEMBER 2023, COMPLAINING ABOUT SORENESS AROUND THE IMPLANT AT TOOTH LOCATION #30. THE DOCTOR PRESCRIBED ANTIBIOTICS FOR INFECTION AND CLEANED AROUND THE IMPLANT

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18325123 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED SEVERAL TIMES FOR INFECTION AROUND THE IMPLANT AT TOOTH LOCATION #30 AND DECIDED TO REMOVE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 18300434 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #19, WITH ASSOCIATED ABSCESS. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18017382 ↗
• InjuryNov 16, 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 INFECTION AND BONE LOSS. TOOTH SITE # 18 (UNIVERSAL). THE SITE WAS GRAFTED. PAIN IS REPORTED AS A SYMPTOM.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 15811367 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED NEUROPATHIC PAIN, POSSIBLE INFECTION. INTENSE PAIN IN SOCKET FOLLOWING REMOVAL OF TOOTH # 46 (UNIVERSAL) AND IMMEDIATE IMPLANT AND GRAFTING, PROBABLE NEUROPATHIC PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15199534 ↗
• InjuryJul 29, 2021Adverse 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. PATIENT WOULD HAVE TO RETURN FOR A NEW IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 12244771 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BNST511) WAS REMOVED DUE TO INFECTION AND BONE LOSS AT TOOTH LOCATION 30. ABSCESS AND INFLAMMATION WERE ALSO NOTED.

  Patient problems: Abscess; Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10408018 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY.

  Patient problems: No Information

  MAUDE report 9078893 ↗