3i T3® SHORT DCD® BNES505Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868033592), received between Oct 1, 2019 and Sep 15, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Separation Failure; Separation Failure

  PER INDICATED: THE MOUNT WON'T COME OFF. THE IMPLANT MOUNT WAS TOO HARD AND COULD NOT BE REMOVED. THEREFORE, THE DOCTOR REMOVED IT AND REPLACED IT WITH A DIFFERENT PRODUCT. TOOTH SITE # 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052084 ↗
• InjurySep 3, 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 #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22952095 ↗
• InjuryJun 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 #12 WAS REMOVED DUE TO INFECTION AND BONE LOSS. DURING THE APPOINTMENT ON (B)(6) 2021, THE PATIENT CAME BACK FOR FOLLOW UP. IN CLINICAL EXAMINATION, THE INFECTION AND INFLAMMATION WAS FOUND ON THE GINGIVA SURROUNDING THE IMPLANT CROWN OF #12 BY REVIEWING A PERIAPICAL RADIOGRAPH. THE MOBILITY WAS II DEGREE. THE PROCEDURE OF EXTRACTION OF #12 IMPLANT WAS PERFORMED. ANOTHER PERIAPICAL RADIOGRAPH WAS TAKEN TO REVIEW THE EXTRACTION SOCKET.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22333096 ↗
• InjuryMay 30, 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 POSITION NUMBER #46 PERFORATED THE SINUS DURING IMPLANTATION AND WAS REMOVED TO AVOID SINUS PENETRATION. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Sinus Perforation

  MAUDE report 22114236 ↗
• MalfunctionFeb 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AFTER PLACING THE IMPLANT, THE DOCTOR DISCOVERED THAT THE HEALING ABUTMENT WAS VERY HARD TO PLACE AND FLOATED WHEN PLACED. THE SAME THING HAPPENED WITH A SECOND HEALING ABUTMENT. IT IS VERY HARD AND DIFFICULT TO WORK WITH IN THE BACK TEETH AREA. THE IMPLANT IS NOT AVAILABLE AS IT HAS ALREADY BEEN IMPLANTED. THE DIAMETER OF THE HEX OF THE IMPLANT SEEMS TO BE LARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356091 ↗
• InjuryJan 8, 2025Adverse 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 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PAIN AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 21100195 ↗
• InjuryJul 1, 2024Adverse 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 47 AND UNKNOWN FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: UNKNOWN. THE DOCTOR REPORTED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19643725 ↗
• InjuryOct 25, 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: Osteolysis; Unspecified Infection

  MAUDE report 18007597 ↗
• InjuryMay 4, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT CAN'T REMOVE MOUNT. AFTER THE MOUNT WAS IMPLANTED, IT DID NOT COME OFF. ACCORDING TO THE DOCTOR, IT IS NOT TIGHTENED WITH A PARTICULARLY STRONG TORQUE VALUE. NO HEALTH HAZARD. TOOTH SITE # 30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872436 ↗
• InjuryFeb 22, 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: Osteolysis; Unspecified Infection

  MAUDE report 16416621 ↗
• InjuryJan 3, 2023Separation Failure; Separation Failure

  THE DOCTOR REPORTS THAT THE MOUNT IS LOCKED TO THE IMPLANT. THE DOCTOR INDICATES THAT THE PROCEDURE WAS NOT CONCLUDED WITH THE PLACEMENT OF ANOTHER IMPLANT. THE AFFECTED DENTAL POSITION IS #36.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090840 ↗
• InjuryAug 30, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS WITH A LOSS OF INTEGRATION AT THE SITE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15320761 ↗
• MalfunctionMar 24, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT AFTER PLACING THE IMPLANT IT WAS NOT POSSIBLE TO REMOVE THE MOUNT. THE DOCTOR CONFIRMED THAT THE DENTAL SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891265 ↗
• MalfunctionDec 5, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE IMPLANT DROPPED DUE TO NOT DISENGAGED FROM TOOL. AFTER ATTEMPT TO DISENGAGE, THE IMPLANT FELL OFF, AND LOST STERILITY SO ANOTHER IMPLANT WAS PLACED. TOOTH NUMBER 30 (UNIVERSAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931336 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH LOCATION # 17 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 11830652 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED FOR IMPLANT BNES505.

  Patient problems: No Information

  MAUDE report 9142085 ↗