3i T3® DCD® BNPT4311Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00844868028338), received between May 29, 2019 and Jun 12, 2025 — classified as 59 injuries.

The most frequently reported specific device problem is “Problem with Sterilization” (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 59 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Adverse 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: Pain

  MAUDE report 22198151 ↗
• InjuryJun 12, 2025Adverse 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22198062 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SEVERE BONE LOSS AROUND THE IMPLANTS AT TOOTH LOCATIONS #23 AND #26. THE IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis

  MAUDE report 22157766 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SEVERE BONE LOSS AROUND THE IMPLANTS AT TOOTH LOCATIONS #23 AND #26. THE IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis

  MAUDE report 22157713 ↗
• InjuryMar 4, 2025Adverse 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 AND BONE LOSS. AT IMPLANT TORQUE TEST, IT WAS DISCOVERED #7 IMPLANT WAS LOOSE AND INFECTED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21514461 ↗
• InjurySep 4, 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20138216 ↗
• InjuryJul 22, 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: Pain; Sinus Perforation; Unspecified Infection

  MAUDE report 19790422 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE OFFICE CLAIMING THAT THE IMPLANT AT TOOTH LOCATION #6 WAS INFLAMED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18885669 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 14 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18496538 ↗
• 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 #8. IMPLANT FAILED THE IST; THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18298686 ↗
• InjuryDec 9, 2023Adverse 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: Erythema; Swelling/ Edema

  MAUDE report 18298105 ↗
• InjuryOct 13, 2023Adverse 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 # 4 . SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis

  MAUDE report 17932509 ↗
• InjurySep 22, 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 # 35, 36 AND 37 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17796564 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #5 WAS REMOVED DUE TO PERI IMPLANTITITIS AND NEW IMPLANT PLACED WITH ALLOGRAFT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17377504 ↗
• InjuryJul 17, 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 #24 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17332354 ↗
• InjuryJul 17, 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 #26 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17331969 ↗
• 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 #46 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17325343 ↗
• 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 16953162 ↗
• 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 16953131 ↗
• 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 16953119 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO POOR IMPLANT PLACEMENT DUE TO POOR STABILITY OF THE SURGICAL SPLINT, LINGUAL PERFORATION OCCURRED AND THE IMPLANT WAS REMOVED. TOOTH LOCATION 31. IMPLANT PLACED AT 80 N TORQUE AND 800 RPM.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675361 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16611439 ↗
• InjuryMar 17, 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 PERI-IMPLANTITIS. TOOTH SITE #13 (UNIVERSAL). THE SITE WAS GRAFTED TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16565386 ↗
• InjuryJan 30, 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 #7 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 16264992 ↗
• InjuryJan 24, 2023Adverse 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: Unspecified Infection

  MAUDE report 16237005 ↗