3i T3® DCD® BNST413Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00844868029168), received between Oct 30, 2019 and Apr 7, 2026 — classified as 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 25 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT DEVELOPED RETROGRADE ABSCESS AFTER IMPLANT PLACEMENT. IMPLANT WAS REMOVED AND SITE WAS DEBRIDED WITH NEW GUIDED BONE REGENERATION. WILL PLACE AN IMPLANT IN THE FUTURE. IMMEDIATE IMPLANT ALLOGRAFT PLACED AT TIME OF IMPLANT PLACEMENT. NOTES ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 24809022 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WAS REMOVED DUE TO INFECTION & BONE LOSS. MOBILITY OF IMPLANT AND LOSS OF BONE SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24308631 ↗
• InjuryDec 31, 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 #13 WAS REMOVED DUE TO INFECTION AND BONE LOSS. THE PATIENT WAS IN A LOT OF DISCOMFORT. AFTER IMPLANT EXTRACTION, A BONE GRAFT WAS PLACED. AN IMPLANT REPLACEMENT IS ANTICIPATED IN APPROXIMATELY FOUR MONTHS.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 23936839 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNSUCCESSFUL REPAIR PROCEDURES WERE ATTEMPTED, THE IMPLANT AT TOOTH LOCATION #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21877335 ↗
• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IMPLANT FELL FROM THE DRIVER ONTO THE FLOOR. THERE IS NO ISSUE WITH THE DRIVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152061 ↗
• MalfunctionSep 16, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224388 ↗
• InjuryMar 22, 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18958165 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION REPORTED. PATIENT HAD DISCOMFORT. TOOTH #7. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17932393 ↗
• InjuryOct 13, 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. TOOTH #29. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17931989 ↗
• InjurySep 18, 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 #14, #16 AND #23 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17763408 ↗
• InjurySep 18, 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 #14, #16 AND #23 FAILED, DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS, THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Physical Entrapment; Unspecified Infection

  MAUDE report 17763370 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS "EDEMA".

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 16272698 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS "EDEMA."

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 16265156 ↗
• MalfunctionMar 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT IMPLANT UNCOVERED W/ENCODE PLACEMENT FLUSH. ON REMOVAL AND RETUNED TO OMFS ENCODE ABUT (OLD AND NEW) DID NOT SEAT FLUSH. ENCODE DID NOT SEAT W/IMPLANT. IMPLANT WAS REMOVED. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. TOOTH # 9.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905381 ↗
• InjuryOct 13, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625119 ↗
• InjuryOct 4, 2021Adverse 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. THE SITE WAS GRAFTED FOR FUTURE IMPLANTATION.

  Patient problems: Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12567257 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING IMPLANT PLACEMENT. DOCTOR DID NOT COMPLETE THE PROCEDURE PLACING OTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286351 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BNST413 IMPLANT WAS REMOVED DUE TO INFECTION. PAIN, ABSCESS AND INFLAMMATION ARE ALSO REPORTED. TOOTH LOCATION #27 (UNIVERSAL). THE SITE WAS GRAFTED WITH AUTOGENOUS BONE GRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Abscess; Inflammation; Pain; Unspecified Infection

  MAUDE report 11752189 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS BONE LOSS, LOSS OF VERTICAL BONE AND EXPOSURE OF THREADS AROUND THE BNST3213 IMPLANT. TOOTH SITE # 15.

  Patient problems: Osteolysis

  MAUDE report 11457174 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANT SITE, TOOTH LOCATION #7. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 11142130 ↗
• InjuryDec 7, 2020Adverse 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; Pain; Unspecified Infection

  MAUDE report 10958572 ↗
• InjuryDec 7, 2020Adverse 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: No Code Available; Unspecified Infection

  MAUDE report 10957531 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAD NO PRIMARY STABILITY AND WAS REMOVED. BONE GRAFT WAS PERFORMED. THREE MONTHS LATER, ANOTHER IMPLANT WAS PLACED.

  Patient problems: No Information

  MAUDE report 10498983 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY DUE TO SOFT BONE WITH IMPLANT BNST413. TOOTH SITE # 11.

  Patient problems: No Information

  MAUDE report 9342336 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS IMPLANT BNST413 WAS PLACED ON (B)(6) 2019 AND REMOVED ON (B)(6) 2019 DUE TO NON INTEGRATION.

  Patient problems: No Information

  MAUDE report 9254982 ↗