3i T3® DCD® BNPT6513Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868029526), received between Feb 4, 2020 and May 7, 2026 — classified as 9 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 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.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25117389 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR RE-EVALUATION OF THE IMPLANT SITE AT TOOTH LOCATION #30 AND A SMALL AMOUNT OF GRANULATION TISSUE WAS NOTED ON THE MF MARGIN. THERE WAS 10 MM PROBING DEPTH ON THE DISTAL AND 8MM PROBING DEPTH ON THE MF. THE IMPLANT WAS NOTED TO BE NON-INTEGRATED. THE IMPLANT WAS REMOVED USING REVERSE TORQUE, THE AREA WAS FINALLY DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE WITH THE OVERALL DEFECT MEASURING APPROX. 6X8MM. THE SITE WAS DECORTICATED. PARESTHESIA ALONG WITH PAIN WERE ALSO REPORTED. CO/CA/XE REGENEROSS BONE WAS MIXED WITH PRF EXUDATE AND USED TO GRAFT THE OSTEOTOMY. PRF MEMBRANE WAS PLACED OVERLYING GRAFT AND SECURED WITH 3-0 CHROMIC.

  Patient problems: Pain; Paresthesia

  MAUDE report 21921686 ↗
• InjuryJan 6, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21087218 ↗
• InjuryDec 3, 2024Adverse 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

  MAUDE report 20831089 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED PARESTHESIA TO HER LEFT LIP/CHIN, STATUS POST PLACEMENT AT #18, IMMEDIATE IMPLANT. THE INFERIOR ALVEOLAR NERVE WAS NOT SEEN OR PALPATED DURING SURGERY, NOR WAS THERE ANY UNUSUAL BLEEDING. POST-OP SENSATION TESTING REVEALED A DEFICIT IN SENSATION ONE WEEK LATER. THE IMPLANT WAS REMOVED.

  Patient problems: Paresthesia

  MAUDE report 18129761 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN IN THE AREA OF THE IMPLANT RESULTING IN IT NEEDING TO BE REMOVED. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE. TOOTH #18

  Patient problems: Pain

  MAUDE report 13316004 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED LACK OF PRIMARY STABILITY. THE IMPLANT WAS REMOVED AND THE AREA WAS GRAFTED. THE PATIENT IS RETURNING FOR FUTURE IMPLANT PLACEMENT. TOOTH LOCATION UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590388 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD A LACK OF PRIMARY STABILITY AND BONE LOSS. NO OTHER IMPLANT HAS BEEN PLACED. TOOTH NUMBER 19.

  Patient problems: No Code Available; Pain

  MAUDE report 10098812 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO LACK OF PRIMARY STABILITY. NO OTHER IMPLANT WAS PLACED DURING THE SAME SURGERY.

  Patient problems: No Information

  MAUDE report 9664206 ↗