3i T3® DCD® BNPT4310Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00844868028321), received between Jun 19, 2020 and Feb 19, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CBCT WAS TAKEN OF THE DENTAL IMPLANTS AT TOOTH SITE #3 AND #4 AFTER THE PATIENT COMPLAINED OF HAVING PAIN AROUND THE IMPLANTS. IT WAS ALSO REPORTED THAT IMPLANT #4 HAD MIGRATED DOWN AND IMPLANT #3 HAD MIGRATED UP. THE IMPLANTS WERE REMOVED DUE TO INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24394230 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED SYMPTOMS AFTER PLACEMENT. CAUSING HEADACHES, DIZZINESS. REMOVED TO SEE IF IMPLANT WAS CAUSING SYMPTOMS. TOOTH NUMBER 4. PATIENT'S SYMPTOMS DID NOT RESOLVE AFTER IMPLANT WAS REMOVED. SYMPTOMS WERE HEADACHES CONSTANTLY. SYMPTOMS AS A RESULT OF THE EVENT: HEADACHES.

  Patient problems: Dizziness; Headache

  MAUDE report 24073148 ↗
• InjuryDec 30, 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 #29 WAS REMOVED DUE TO INFECTION. DURING THE EVALUATION, INFECTION AND SWELLING WAS NOTICED ON THE BUCCAL OF THE IMPLANT. X-RAY IMAGING REVEALED RADIOLUCENCY AT THE APEX OF THE IMPLANT. THE SITE WAS GRAFTED AFTER THE IMPLANT IN ANTICIPATION OF A REPLACEMENT IMPLANT AT A LATER TIME.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 23927718 ↗
• InjuryAug 16, 2025Adverse 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; Unspecified Infection

  MAUDE report 22823049 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #4 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22588139 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. PARULIS ASSOCIATED WITH IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22353131 ↗
• InjuryMay 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21, #23, #26, & #28 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT, INFLAMMATION; PAIN & SWELLING.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21957220 ↗
• InjuryMay 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21, #23, #26, & #28 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT, INFLAMMATION; PAIN & SWELLING.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21956461 ↗
• InjuryMay 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21, #23, #26, & #28 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT, INFLAMMATION; PAIN & SWELLING.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21956440 ↗
• InjuryMay 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #21, #23, #26, & #28 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT, INFLAMMATION; PAIN & SWELLING.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21956425 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #36 FAILED DUE TO INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 21545428 ↗
• InjuryNov 20, 2024Adverse 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20731831 ↗
• InjuryOct 3, 2024Adverse 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. TOOTH #5 (UNIVERSAL). PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20358294 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #12 (UNIVERSAL) WAS REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20358210 ↗
• InjuryAug 14, 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 #12 HAD PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, DEHISCENCE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19984712 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III. THE DOCTOR REPORTED : POOR ORAL HIGYENE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19816580 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AND INFECTION AT IMPLANT TOOTH SITE #11, WITH ASSOCIATED PAIN, EDEMA AND INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18862541 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FISTULA THAT FORMED ASSOCIATED WITH THE IMPLANT. WENT IN FOR AN EXPLORATION OF THE IMPLANT. TOOTH #4. THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 18836766 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #13. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18333311 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #25 & #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319827 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #5 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17444055 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN REPORTED PATIENT COMPLAINED OF DULL ACHE LEFT MANDIBLE APPROX 2 MONTHS LATER AFTER IMPLANT PLACEMENT. HEALING ABUTMENT WAS PLACED EARLY ON (B)(6) 2023 BUT SYMPTOMS PERSISTED AND IMPLANT WAS REMOVED ON (B)(6) 2023. WILL RETURN FOR POSSIBLE IMPARTMENT IN THE FUTURE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17341917 ↗
• 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 #36 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17326232 ↗
• 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 #23 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17321674 ↗
• 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 16953092 ↗