3i T3® BOPT6511Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00844868029861), received between Nov 22, 2019 and Jan 23, 2026 — classified as 38 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 LOST INTEGRATION OVER TIME AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24160676 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20565168 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20544451 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #45/47 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20543532 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SEEN IN HIS GENERAL DENTIST OFFICE WHEN HIS DENTIST NOTICED INFLAMMATION AROUND IMPLANT #30. PATIENT WAS SENT TO OUR OFFICE FOR US TO EXAMINE THE IMPLANT. AFTER EXAMINATION OF THE IMPLANT. DR. SCANLON EXPLAINED THE IMPLANT NEEDED TO BE REMOVED DUE TO INFECTION. IMPLANT WAS REMOVED IN OFFICE ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 19466628 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH # 22 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19231834 ↗
• InjuryApr 22, 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 #18 SUFFERED FROM INFECTION & WAS REMOVED. PATIENT CAME IN WITH PAIN, SITE INFECTED & IMPLANT REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 19152398 ↗
• InjuryFeb 21, 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 # 14 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 18747529 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BASED ON ADDITIONAL INFORMATION RECEIVED, THE IMPLANT EXFOLIATED TWO (2) WEEKS AFTER PLACEMENT DUE TO NON-INTEGRATION. THERE WAS NO INJURY, SIGNIFICANT DELAY AND NO ALLEGED FAILURE OF THE DEVICE. THEREFORE, THIS EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. AS A RESULT, THE PRIOR SUBMISSIONS FOR MFR- SUBMITTED ON DECEMBER 4, 2023 IS NO LONGER CONSIDERED A REPORTABLE EVENT BY THE MANUFACTURE AND NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT.

  Patient problems: Osteolysis

  MAUDE report 18255961 ↗
• InjuryNov 22, 2023Mechanical Problem; Mechanical Problem

  DENSE BONE TAP WAS USED, BUT THE IMPLANT WOULD NOT SEAT COMPLETELY INTO OSTEOTOMY. THE IMPLANT WOULD NOT GO FURTHER AND WOULD NOT COME OUT. AS RESULT, I DAMAGED THE INTERNAL HEX. I HAD TO USE A HANDPIECE TO CUT AROUND THE IMPLANT TO REMOVE. THE SITE WAS GRAFTED WITH PUROS CORTICAL AND AN OSSIX(+) MEMBRANE AND PRIMARY CLOSURE. TOOTH 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190530 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME BACK MONTHS LATER IN PAIN, HEADACHE, INFLAMED BONE. TOOTH #30. I WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18123835 ↗
• MalfunctionAug 9, 2023Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486774 ↗
• InjuryJun 5, 2023Component Missing; Component Missing

  THE SALES REPRESENTATIVE REPORTED THAT THERE WAS NO IMPLANT IN THE BOX WHEN THE CUSTOMER OPENED IT. THE IMPLANT WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058681 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Pain

  MAUDE report 16611936 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Pain

  MAUDE report 16611907 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 16426497 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON REFLECTING THE TISSUE OF IMPLANT NUMBER 30, DOCTOR NOTED THIS FISTULA WAS A LARGE INFECTION THAT CAUSED BONE LOSS. IMPLANT WAS REMOVED. THE AREA WAS GRAFTED WITH ALLOGRAFT PRIOR TO THE ORIGINAL IMPLANT PLACEMENT.

  Patient problems: Fistula; Osteolysis; Unspecified Infection

  MAUDE report 16297765 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE INTEGRATED IMPLANT AT TOOTH LOCATION #3. REMOVED THE IMPLANT AND PLACED BONE GRAFT.

  Patient problems: Osteolysis

  MAUDE report 14696590 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. IMPLANT WAS WELL INTEGRATED BUT A FISTULA WAS PRESENT ON THE BUCCAL MED-ROOT. SURGERY REVEALED NON-GRAFTABLE CIRCUMFERENTIAL LESION. REMOVED, CLEANED GRAFTED, TOOTH # 30.

  Patient problems: Unspecified Infection

  MAUDE report 14570459 ↗
• InjuryJan 21, 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 INFECTION AND BONE LOSS. IT WAS NOT INDICATED IF THE PATIENT WILL RETURN FOR ADDITIONAL APPOINTMENTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13317037 ↗
• InjuryDec 13, 2021Mechanical Problem; Mechanical Problem

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12982834 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

  Patient problems: Inadequate Osseointegration; Paresthesia

  MAUDE report 12747284 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY. THE IMPLANT WAS NOT IN THE PATIENT MOUTH MORE THAN 20 MINUTES TOOTH #31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636506 ↗
• InjuryOct 1, 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 BONE LOSS. GENERAL DENTIST SENT PATIENT FOR BONE LOSS. IMPLANT NEEDED TO BE REMOVED.

  Patient problems: Osteolysis

  MAUDE report 12560958 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIAN REPORTED LACK OF PRIMARY STABILITY, SPINNER AT SITE # 19. IMPLANT REMOVED AREA GRAFTED INSTEAD. PATIENT RETURNING FOR FUTURE IMPLANT PLACEMENT. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803060 ↗