3i T3® DCD® BNPT4385Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00844868028352), received between May 18, 2020 and May 13, 2026 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 34 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN, INFLAMMATION AND ABSCESS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25159635 ↗
• InjuryNov 25, 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 #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23644001 ↗
• InjuryNov 14, 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 #22 WAS REMOVED DUE TO BONE LOSS. THE PATIENT NO LONGER WANTS THE IMPLANT. SHE HAS TO TELL THE DOCTOR WHEN SHE FELT IT ON THE GUM OF THE MOUTH. THE IMPLANT HAS NEVER BEEN RESTORED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 23555117 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 LOST INTEGRATION DUE TO PERIIMPLANTITIS AND WAS REMOVED. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, BONE GRAFTING ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFLAMMATION & PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21000167 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION AFTER IMPLANT PLACED. SEVERAL ROUNDS OF ANTIBIOTICS. REMOVED IMPLANT, GRAFTED SITE. WILL REPLACE IN 6 MONTHS. TOOTH #30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19587892 ↗
• InjuryDec 21, 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 #8. THE IMPLANT FELL OUT AT THE PATIENT'S HOME.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18370857 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANT WAS REMOVED DUE TO AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049619 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #25 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17325833 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #25 FAILED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17321376 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI-IMPLANTITIS IS REPORTED. PATIENT RECEIVED ALL ON 6 IMPLANT. AFTER 4 YEARS OF FUNCTIONING, THE PATIENT CAME BACK WITH PAINFUL FEELING, WE CHECKED ON THE CBCT AND NOTICED AND THE BONE LOSS, PERI-IMPLANTITIS, THE LOSS INTEGRATION. WE DECIDED REMOVING IMPLANT. DR COULD EASILY REMOVE THE IMPLANT WITH THE HAND IMPLANT HOLDER. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. TOOTH SITES # 46-36-44-42-32-34 (FDI).

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16953182 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI-IMPLANTITIS IS REPORTED. PATIENT RECEIVED ALL ON 6 IMPLANT. AFTER 4 YEARS OF FUNCTIONING, THE PATIENT CAME BACK WITH PAINFUL FEELING, WE CHECKED ON THE CBCT AND NOTICED AND THE BONE LOSS, PERI-IMPLANTITIS, THE LOSS INTEGRATION. WE DECIDED REMOVING IMPLANT. DR COULD EASILY REMOVE THE IMPLANT WITH THE HAND IMPLANT HOLDER. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. TOOTH SITES # 46-36-44-42-32-34 (FDI).

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16953105 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN, AND INFECTION WAS DISCOVERED WITH ABSCESS SHOWING ON RADIOGRAPH AROUND THE IMPLANT AT TOOTH LOCATION #28. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 16304997 ↗
• 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 15405682 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICIAN REMOVED IMPLANT DUE TO INFECTION. TOOTH SITE # 3.

  Patient problems: Unspecified Infection

  MAUDE report 14142034 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH SITE # 13.

  Patient problems: Unspecified Infection

  MAUDE report 13541445 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE IMPLANT LOCATED IN DENTAL POSITION NUMBER #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH AND CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY. PAIN WAS ALSO REPORTED.

  Patient problems: Implant Pain; Osteolysis; Pain; Unspecified Infection

  MAUDE report 12587935 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED LACK OF PRIMARY STABILITY AT TOOTH SITE 35. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12021002 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH LOCATION 20.

  Patient problems: No Code Available

  MAUDE report 11107865 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DEVELOPED PERI-IMPLANTITIS. IMPLANT WAS REMOVED AND IT WAS NOT INDICATED IF THE PATIENT WOULD RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #18.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10065707 ↗