3i T3® DCD® BNSS510Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868029199), received between Mar 27, 2020 and Jun 12, 2026 — classified as 12 injuries, 1 malfunction.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXUDATE WAS NOTED AROUND THE IMPLANT AT TOOTH SITE #30 DURING CLEANING WITH PRESSURE AT THE SITE. A PA SHOWED A FAILING IMPLANT WITH MODERATE BONE LOSS. THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25490575 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF CONSISTENT PAIN #18. PAIN AT BUCCAL OF SITE. IMPLANT REMOVED DUE TO CONSISTENT PAIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 24630848 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED WITH PAIN. AN X-RAY WAS TAKEN SHOWING LUCENCY AT THE APEX OF THE IMPLANT AT TOOTH LOCATION #19. THE DOCTOR RECOMMENDED REMOVAL OF THE IMPLANT BEFORE INFECTION BECOMES PROBLEMATIC. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22235295 ↗
• InjuryFeb 13, 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 PERI-IMPLANTITIS. IMPLANT #19 WAS PLACED ON (B)(6) 2023. PT STAGE II UNCOVERY ON (B)(6) 2024. IMPLANT #19 HAS MOBILITY. IMPLANT EXPLANTED, DEGRANULATED WITH SITE BONE GRAFTED PLACED. WILL REPLACE ANOTHER IMPLANT AFTER 6 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21374754 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED NO STABILITY AND IMPLANT REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20464062 ↗
• InjuryDec 15, 2023Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341319 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED PERI-IMPLANTITIS, AT 2ND STAGE PROCEDURE, BONE ON CORONAL HALF OF IMPLANT HAD RESORBED EXPOSING SEVERAL THREADS, TOOTH 19 (UNIVERSAL). IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED. THE SITE WAS ALSO GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16868610 ↗
• MalfunctionJan 25, 2023Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240100 ↗
• InjuryJun 24, 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 IMPLANT SITE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14800256 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH THE DENTAL IMPLANT IN TOOTH SITE # 20 (UNIVERSAL). BONE GRAFT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590500 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL PROCEDURE FOR IMPLANT PLACEMENT, THERE WAS NO PRIMARY STABILITY AND THE IMPLANT WAS REMOVED. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT. PATIENT WILL BE RETURNING FOR FUTURE IMPLANT PLACEMENT. TOOTH LOCATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307928 ↗
• InjuryJul 16, 2020Adverse 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. PATIENT ALSO HAD INFLMMATION. NEW IMPLANT WOULD BE PLACED IN 3 MONTHS.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10281885 ↗
• InjuryMar 27, 2020Adverse 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. CUSTOMER ALSO REPORTED ABSCESS AND DEHISCENCE. TOOTH LOCATION 14.

  Patient problems: Abscess; Unspecified Infection; Wound Dehiscence

  MAUDE report 9889175 ↗