3i T3® DCD® BNST3211Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00844868029106), received between Dec 4, 2019 and Jul 24, 2025 — classified as 47 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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. 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #33 FAILED BECAUSE IT FRACTURED BY THE BODY. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585350 ↗
• 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 #11 FAILED THE STABILITY TEST AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22080685 ↗
• InjuryMay 9, 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 INCORRECT LENGTH IMPLANT, SWITCHED TO A 10MM LENGTH DUE TO PROXIMITY TO MENTAL NERVE, CHANGED FROM 11.5MM TO 10MM. TOOTH LOCATION: 21.

  Patient problems: Nerve Damage

  MAUDE report 21993514 ↗
• InjuryMar 18, 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 BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21635055 ↗
• InjurySep 26, 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 #25 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20308408 ↗
• InjurySep 25, 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 #44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20300045 ↗
• InjurySep 20, 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 #28 WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 20271240 ↗
• InjurySep 20, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264858 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ABSCESS WAS NOTED AROUND THE IMPLANT AT TOOTH LOCATION #27. THE IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20249660 ↗
• InjuryAug 20, 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: IV.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20004450 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT #27 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19480610 ↗
• InjuryApr 29, 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. IMPLANT #24 ABSCESS PRESENT AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19203421 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLAMMATION AT IMPLANT TOOTH SITE #7. THE TISSUE WAS INFLAMED, NOT HEALING AND BLEEDING. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Inflammation

  MAUDE report 19195604 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNCONTROLLED PAIN IN IMPLANT SITE 27. IMPLANT WAS INFECTED AND REMOVED. NOTED PAIN, INFLAMMATION AND EDEMA. WILL RETURN FOR FUTURE APPOINTMENT. NO MEDICAL HISTORY REPORTED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19118223 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION WITH RADIOLUCENCY AROUND IMPLANT AT TOOTH SITE #27. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18585048 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED BONE LOSS TO SECOND THREAD OF IMPLANT #7 (UNIVERSAL). IMPLANT WAS REMOVED. ALLOGRAFT.

  Patient problems: Osteolysis

  MAUDE report 18520045 ↗
• InjuryOct 9, 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. IMPLANT WAS PLACED FOR A FULL ARCH. MULTI UNIT ATTACHED TO IMPLANT, TOOTH 10.

  Patient problems: Unspecified Infection

  MAUDE report 17901545 ↗
• InjurySep 26, 2023Adverse 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 #26 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PATIENT FELT PAIN AND SITE PRESENTED ABSCESS AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 17816547 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WITH SCREW AND CROWN AT TOOTH SITE # 7 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17349969 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #24 AND #25 FAILED AND WERE REMOVED DUE TO PERI-IMPLANTITIS. OTHER SYMPTOM AS A RESULT OF EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 17327236 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #24 AND #25 FAILED AND WERE REMOVED DUE TO PERI-IMPLANTITIS. OTHER SYMPTOM AS A RESULT OF EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 17327114 ↗
• 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 #12 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 17325041 ↗
• 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 #42 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 17324899 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS WAS PRESENT AROUND THE IMPLANT AT TOOTH LOCATION #7. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 16947468 ↗
• InjuryMay 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR NOTICED BONE LOSS AND PERI-IMPLANTITIS AFTER TWO (2) MONTHS THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16883064 ↗