3i T3® DCD® BNPT5485Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00844868028383), received between Sep 3, 2019 and Sep 3, 2025 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #26. IMPLANT WAS REMOVED AND THE PROCEDURE WAS COMPLETED. PATIENT REFERRED INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22952060 ↗
• InjuryMay 24, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22082201 ↗
• InjuryMay 24, 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 PERI-IMPLANTITIS. DENTAL IMPLANT SITE # 14. SYMPTOMS: PAIN AND EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22082185 ↗
• InjuryMay 23, 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 FELL OUT WHILE THE PATIENT WAS AT HOME DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22080199 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER INDICATED: CALLED CLINICIAN AND THEY REPORTED #5 ABSCESS INFECTION SEVERE BONE LOSS. NOTED SMOKER PATIENT. THE IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES TO REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. GRAFTED: ALLOGRAFT. BONE TYPE: 2. TOOTH SITE: 5.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22023910 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #15, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19039010 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT REFERRED PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18957281 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH EDEMA, FISTULA AND INFLAMMATION. PATIENT REFERRED PAIN.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 18957222 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AT IMPLANT TOOTH SITE #4, WITH ASSOCIATED INFLAMMATION. THE IMPLANT MOBILE, THEREFORE, IT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 18412099 ↗
• InjuryDec 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #4. DOCTOR NOTED IMPLANT FAILED IST TEST; THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18298679 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH SITE 36. DOCTOR ALSO INDICATED INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18144557 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CONFIRMED IMPLANT REMOVED DUE TO BONE LOSS. TOOTH SITE IS # 19. SITE WAS GRAFTED WITH ALLOGRAFT WHEN IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 18049471 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #19 AND #20 WERE REMOVED DUE TO NERVE DAMAGE. SYMPTOMS OF THE EVENT: PARESTHESIA AND NUMBNESS.

  Patient problems: Nerve Damage; Numbness

  MAUDE report 15405586 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #4, #12, #20, #30, #31 WERE REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15232412 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #4, #12, #20, #30, #31 WERE REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15232410 ↗
• InjuryAug 8, 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 INFECTION AT THE IMPLANT SITE.

  Patient problems: Unspecified Infection

  MAUDE report 15182639 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO AN INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 12218062 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sinus Perforation

  MAUDE report 11971038 ↗
• 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 11322031 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR COULD NOT ACHIEVE PRIMARY STABILITY AND WAS UNABLE TO PLACE THE IMPLANT INTO THE PATIENT'S OSTEOTOMY.

  Patient problems: No Information

  MAUDE report 8955447 ↗