3i T3® DCD® BNPT6510Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00844868029502), received between Jan 16, 2020 and Apr 16, 2026 — classified as 24 injuries, 2 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT FAILED IST AND IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24896609 ↗
• 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 24781511 ↗
• InjuryJun 12, 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 #3 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22198654 ↗
• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2022 REMOVED ON (B)(6) 2022.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20975735 ↗
• InjuryNov 25, 2024Adverse 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: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 20770384 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 20620851 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS, IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19982300 ↗
• InjuryMar 18, 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 #19 SUFFERED FROM BONE LOSS AND WAS REMOVED. THE PATIENT IS CURRENTLY BEING WORKED UP FOR LUPUS. THE PATIENT HAD ANOTHER IMPLANT PLACED IN A SLIGHTLY LARGER OSTEOTOMY.

  Patient problems: Osteolysis

  MAUDE report 18922665 ↗
• InjuryOct 18, 2023Adverse 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 INFECTION AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17957391 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SUPPLEMENTAL IS BEING REPORTED AS A CORRECTION. THIS EVENT WAS INITIALLY CREATED/SUBMITTED TO FDA UNDER COMPLAINT NUMBER, (B)(4) ON 10/12/23 UNDER THE WRONG MFR NUMBER (0002023141-2023-02871). TO CORRECT THE ERROR, A NEW COMPLAINT (B)(4) WAS OPENED AND THIS EVENT WAS REPORTED UNDER THE CORRECT MFR NUMBER (0001038806-2023-02002). THEREFORE, ALL DETAILS RELATED TO THIS EVENT WILL BE CAPTURED UNDER THE NEW COMPLAINT (B)(4), MFR NUMBER (0001038806-2023-02002).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17918878 ↗
• InjuryFeb 2, 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 #19 WAS REMOVED DUE TO AN INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. INFLAMMATION.

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 16284331 ↗
• 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 #14 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 16265043 ↗
• InjuryJan 26, 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 BONE LOSS. TOOTH SITE #8.

  Patient problems: Osteolysis

  MAUDE report 16245413 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO PAIN. BONE GRAFT WAS PLACED TIME OF IMPLANT REMOVAL. NEW IMPLANT WAS PLACED ON (B)(6) 2022. UNCOVERING WAS ALSO DONE ON (B)(6) 2022. TOOTH 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 15762610 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED TENDERNESS TO BITING PRESSURE AT TOOTH SITE #19 AND RADIOGRAPHS SHOWED BONE LOSS AND INFECTION AROUND THE IMPLANT. REMOVED THE IMPLANT, CURRETTED THE SITE TO REMOVE THE SOFT TISSUE AND PLACED BONE GRAFT.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 14372557 ↗
• MalfunctionMar 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT WAS PLACED AND WOULD NOT SEAT PROPERLY AND WAS REMOVE ANOTHER IN THE CUSTOMER'S INVENTORY WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901596 ↗
• InjuryFeb 10, 2022Adverse 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 AT THE IMPLANT SITE.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 13504834 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO MEDICAL BONE LOSS. THE PATIENT BIT INTO A PEACH AND HEARD A CRACK NOISE AND THE IMPLANT AREA WAS TENDER. X-RAY SHOWED DECREASED DENSITY AT THE MESIAL ASPECT OF #3 NEAR THE APEX AND CRESTALLY APPEARS TO BE MORE PROMINENT TO PRIOR X-RAYS. THE PATIENT CALLED TO SAY THE IMPLANT WAS LOOSE AND LATER CALLED TO SAY THAT THE IMPLANT HAD FALLEN OUT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 13423777 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THERE WAS NO STABILITY AT PLACEMENT. IMPLANT REMOVED AND AREA GRAFTED WITH ALLOGRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514235 ↗
• MalfunctionJul 15, 2021Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172472 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO INFECTION. SITE GRAFTED. PATIENT RETURNING FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, SWELLING & PAIN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11678432 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INCREASING DISCOMFORT AND SWELLING REQUESTING IMPLANT AT TOOTH SITE #29 TO BE REMOVED DUE TO INFECTION. ADDITIONAL APPOINTMENTS / IMPLANT RE-PLACEMENT: NOT INDICATED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, DISCOMFORT AND SWELLING.

  Patient problems: Discomfort; Swelling; Unspecified Infection

  MAUDE report 10835349 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE ORIGINAL DESCRIPTION THAT WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 10514776 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT PATIENT PRESENTED WITH INFECTION AND BONE LOSS AROUND THE BNPT6510 IMPLANT IN TOOTH SITE #29. THE IMPLANT WAS REMOVED. THE SITE WAS GRAFTED WITH ALLOGRAFT AND MEMBRANE WAS PLACED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10039748 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT POST-OPERATIVE INFECTION AT IMPLANT SITE. THE IMPLANT WAS REMOVED AND THE SITE GRAFTED. PATIENT TO RETURN FOR FUTURE IMPLANT REPLACEMENT.

  Patient problems: Edema; Inflammation; Pain

  MAUDE report 9627772 ↗