3i T3® DCD® BNPT5413Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844868029489), received between Jan 3, 2020 and Jul 18, 2023 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR UNCOVERING AND DURING THE PROCESS OF PROSTHETIC RESTORATION THE FINAL ABUTMENT WAS VERIFIED TO BE SEATED. HOWEVER, THE IMPLANT AT TOOTH SITE # 7 WAS REMOVED DUE TO PERI-IMPLANTITIS. AFTER EXTRACTION, THE SITE WAS GRAFTED WITH ALLOGRAFT. SITE WAS ALSO GRAFTED WITH ALLOGRAFT. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17346615 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED NORMAL PLACEMENT AT TIME OF SURGERY. GOOD PRIMARY STABILITY SIGNIFICANT BONE LOSS, PROGRESSIVE INFECTION, PATIENT COMPLIANCE. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, BONE LOSS, ABSCESS, PAIN, INFLAMMATION, EDEMA, PAIN.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16565164 ↗
• InjuryJun 10, 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 PAIN AT THE SITE. THE IMPLANT WAS WIGGLING. TOOTH #9.

  Patient problems: Pain

  MAUDE report 14652987 ↗
• InjuryMay 12, 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 PAIN AND SWELLING AT THE IMPLANT SITE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14378533 ↗
• InjuryDec 3, 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 AN INFECTION AT THE SITE. TOOTH #15.

  Patient problems: Unspecified Infection

  MAUDE report 12925048 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS UNABLE TO PLACE INTO OSTEOTOMY. IMPLANT LACKED OF PRIMARY STABILITY AND IT WAS REMOVED. TOOTH LOCATION 8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688759 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 13 LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED IN THE SURGERY.

  Patient problems: No Information

  MAUDE report 10875379 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BNPT5413) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 30. ABSCESS WAS ALSO REPORTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9920588 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PATIENT PRESENTED WITH INFECTION AROUND IMPLANT BNPT5413 IN TOOTH SITE # 9. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9548886 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PATIENT PRESENTED WITH INFECTION AROUND IMPLANT BNPT5413 IN TOOTH SITE #8. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9548864 ↗