3i T3® DCD® BNST510Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868029298), received between Jun 5, 2020 and Jul 14, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1ST ROUND OF ANTIBIOTICS PRESCRIBED DUE TO INFECTION. SYMPTOMS: SWELLING, INFLAMMATION & PAIN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22495494 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2ND ROUND OF ANTIBIOTICS PRESCRIBED DUE TO INFECTION. SYMPTOMS: SWELLING, INFLAMMATION & PAIN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22495491 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20097538 ↗
• InjuryJun 5, 2024Adverse 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 #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19465813 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19310345 ↗
• InjurySep 28, 2023Failure to Osseointegrate; Failure to Osseointegrate

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Sinus Perforation; Swelling/ Edema; Unspecified Infection

  MAUDE report 17830865 ↗
• InjurySep 27, 2023Adverse 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 #26 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17823556 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16557370 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16557206 ↗
• InjuryJan 31, 2023Adverse 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 #30 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS "ABSCESS".

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 16273162 ↗
• InjuryAug 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 AT THE SITE WITH PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 15278566 ↗
• InjuryDec 13, 2021Mechanical Problem; Mechanical Problem

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12982738 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hypoesthesia

  MAUDE report 12726977 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 SPUN UPON PLACEMENT AFTER OSTEOTOMY WAS PREPARED AND WAS REMOVED. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, REPLACEMENT SYMPTOMS AS A RESULT OF THE EVENT: NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12205477 ↗
• InjuryApr 20, 2021Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Discomfort; Pain

  MAUDE report 11693328 ↗
• InjuryJun 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE THAT REQUIRED IMPLANT REMOVAL. PATIENT WILL RETURN IN 3 MONTHS FOR NEW IMPLANT. TOOTH #30.

  Patient problems: Unspecified Infection

  MAUDE report 10122836 ↗