3i T3® DCD® BNST485Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868029182), received between Nov 5, 2020 and Jan 7, 2026 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23990327 ↗
• InjuryOct 21, 2025Adverse 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 BONE LOSS. TOOTH SITE #34.

  Patient problems: Osteolysis

  MAUDE report 23346354 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SEVERE PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21162570 ↗
• InjuryAug 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19899526 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH #21. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 17931681 ↗
• InjuryFeb 3, 2023Adverse 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. PAIN AND SWELLING ARE REPORTED. TOOTH SITE # 30.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16294986 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15072723 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15072707 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT HE WAS UNABLE TO PLACE THE DENTAL IMPLANT LOCATED IN POSITION #46 BECAUSE IT DID NOT OBTAIN PRIMARY STABILITY. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE EFFECTS ON HIS HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598105 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS UNABLE TO BE PLACED INTO OSTEOTOMY. IMPLANT LACK OF PRIMARY STABILITY, BONE WAS TOO SOFT AND IMPLANT WAS REMOVED. TOOTH LOCATION 4.

  Patient problems: No Information

  MAUDE report 11321961 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT FELT PAIN AND THE SITE PRESENTED AN ABSCESS. PATIENT ALSO HAS PAIN.

  Patient problems: Abscess; No Information; Pain; Unspecified Infection

  MAUDE report 11213871 ↗
• 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 BONE LOSS.

  Patient problems: No Code Available

  MAUDE report 10799875 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION 19 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10790941 ↗