3i T3® DCD® BNPT5411Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00844868028376), received between Sep 24, 2019 and Apr 3, 2026 — classified as 45 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

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 49 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 AND #37 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24783461 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POOR LONG-TERM PROGNOSIS OF IMPLANT PLACEMENT. TOOTH #29. IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992955 ↗
• InjuryMar 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21690120 ↗
• InjuryNov 8, 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; Pain

  MAUDE report 20642832 ↗
• MalfunctionOct 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO HAVING THE INTERNAL HEX STRIPPED. IMPLANT PLACED UPON FINAL TORQUE INTERNAL HEX STRIPPED, IMPLANT REMOVED. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20485862 ↗
• InjurySep 24, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, INFLAMMATION, AND PAIN.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20295733 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20290294 ↗
• InjuryAug 28, 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20088065 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 19512208 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT HAD A BUMP AND DISCOMFORT THAT CAME AND WENT SINCE IMPLANT WAS PLACED. TOOTH #30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 18862327 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING FOLLOW UP VISIT PATIENT HAD GRANULATION TISSUES COMING FROM THE KNOWN LOCATION OF THE IMPLANT. PATIENT WAS SCHEDULED FOR A DEBRIDEMENT OF THE AREA. IMPLANT WAS NOT INTEGRATED FULLY. TOOTH #29. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18322605 ↗
• InjuryOct 26, 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 #30, WITH ASSOCIATED ABSCESS. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18017397 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS WITH PAIN. ANOTHER IMPLANT WAS PLACED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17901664 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT A CROWN SEAT APPOINTMENT, THE PATIENT UNDERWENT AN X-RAY WHICH SHOWED SEVERE BONE LOSS AT IMPLANT TOOTH SITE #11. THE PATIENT ALSO HAD SOME CONCERNING SWELLING. AT 4 MONTHS TORQUE TEST WAS FINE BUT THE 2 MONTH X-RAY REVEALED BONE LOSS. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Swelling/ Edema

  MAUDE report 17742407 ↗
• InjurySep 12, 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 #3, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17730739 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 3 FELL OUT WHILE THE PATIENT WAS AT HOME. THE IMPLANT AND ABUTMENT WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17350454 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS AT IMPLANT SITE. IMPLANT PLACED ON (B)(6) 2022, INSERTIONAL TORQUE TEST FAILED ON (B)(6) 2022, PATIENT PLACED ON ANTIBIOTICS, RADIOGRAPHIC IMAGED ON (B)(6) 2023 SHOWED BONE LOSS AND THE DOCTOR NOTED ERYTHEMA AND PURULENCE. IMPLANT WAS REMOVED ON (B)(6) 2023. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

  Patient problems: Erythema; Osteolysis; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 16811860 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THERE WAS COMPLETE LOSS OF FACIAL BONE AND CIRCUMFERENTIAL GRANULATION TISSUE ENCOUNTERED AROUND THE IMPLANT AT TOOTH LOCATION # 30 DURING UNCOVER AND STABILITY TEST. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 16555016 ↗
• InjuryJan 25, 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 AT THE IMPLANT SITE.

  Patient problems: Unspecified Infection

  MAUDE report 16239938 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 12, 13, AND 14 WERE REMOVED DUE TO INFECTION. NOTED PATIENT HAD POST NASAL DRIP AND CONGESTION. SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: POST NASAL DRIP, CONGESTION AND INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15380335 ↗
• MalfunctionAug 26, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO SEAT ENCODE OR IMPRESSION COPING DUE TO DAMAGE ON THE INTERNAL THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300025 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT FOLLOWED-UP IN OFFICE COMPLAINED OF MOBILE CROWN WITH SOME TENDERNESS, X-RAY WAS TAKEN WITH NOTED BONE LOSS AROUND IMPLANT. IMPLANT WAS REMOVED. TOOTH #12.

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

  MAUDE report 15156263 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED INFECTION AND EXTREME PAIN ON IMPLANT SITE #31. IT WAS REMOVED. SYMPTOMS OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15085006 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 LOST INTEGRATION AND WAS REMOVED. DOCTOR DID TORQUE TEST AND IMPLANT FAILED, INFECTION. PAIN INCREASED WITH TORQUE TEST. REMOVED IMPLANT AND CLEANED OUT INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14644022 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #13 WAS STABLE WITH NO SIGNS OF INFECTION, BUT THE PATIENT REPORTED INCREASING PAIN. THE IMPLANT WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 14514479 ↗