3i T3® DCD® BNSS411Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868029045), received between Feb 6, 2020 and Dec 12, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912109 ↗
• InjuryNov 29, 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 #12 WAS REMOVED DUE TO PERIIMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18226104 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT #29 HAD A PROBE DEPTH OF 8MM ON THE BUCCAL. AFTER FLAP REFLECTION, THERE WAS A FENESTRATION AT THE APEX OF THE IMPLANT. THE IMPLANT WAS SUBSEQUENTLY REMOVED DUE TO BONE LOSS, AND THE SITE WAS GRAFTED WITH PUROS AND OSSEO GUARD MEMBRANE.

  Patient problems: Osteolysis

  MAUDE report 17083413 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT 2ND STAGE, THE IMPLANT AT TOOTH LOCATION #13 WAS FOUND TO HAVE A 7MM DEHISCENCE ON THE BUCCAL. LONG TERM PROGNOSIS WAS POOR AND SO THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 14622448 ↗
• InjuryNov 11, 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. AS A RESULT OF THE EVENT PATIENT HAD INFLAMMATION.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 10822958 ↗
• InjuryNov 6, 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. SITE PRESENTED ABSCESS.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10799905 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BNSS411) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 21. DOCTOR NOTICED MILD SWELLING AND PUS AFTER POST-OP FOLLOW UP VISIT. ANTIBIOTICS WERE PRESCRIBED AND IMPLANT WAS REMOVED 5 DAYS LATER. ABSCESS WAS ALSO NOTED.

  Patient problems: Abscess; Swelling; Unspecified Infection

  MAUDE report 10554221 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT UNCOVERING, IMPLANT AT TOOTH SITE # 22 WAS REMOVED DUE TO BONE LOSS. SITE WAS GRAFTED FOR FUTURE RE-PLACEMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10519210 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (B)(4) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 6. PAIN WAS ALSO REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9677630 ↗