3i T3® BOPS4311Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868028406), received between Oct 5, 2020 and Apr 10, 2024 — classified as 13 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AND INFECTION AT UNKNOWN IMPLANT TOOTH SITE. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19085422 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON FOLLOW UP, IMPLANT PLACEMENT AND REMOVAL DATES WERE UPDATED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18967498 ↗
• InjuryMar 18, 2024Adverse 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 & INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18926227 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE DAY OF THE POST-OP VISIT, THE PATIENT SHOWED UP WITH THE IMPLANT FROM TOOTH LOCATION #12 IN A PLASTIC BAG. THEY PERFORMED A CURETTAGE AND DISCOVERED A SIGNIFICANT ABSENCE OF THE BUCCAL PLATE. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 17290490 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, BONE LOSS AND ABSCESS WITH INFLAMMATION AT TOOTH SITE #6. THE IMPLANT WAS REMOVED.

  Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17032181 ↗
• InjuryApr 14, 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 36 WAS REMOVED DUE TO INFECTION. OSTEOPOROSIS.

  Patient problems: Unspecified Infection

  MAUDE report 16742998 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4 AND #13 WERE REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16285687 ↗
• InjuryDec 29, 2022Adverse 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: Abscess; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16067363 ↗
• InjuryJul 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS, WITH INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 12186195 ↗
• InjuryMar 19, 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 WITH INFECTION, LOSS OF INTEGRATION, PAIN AND INFLAMMATION. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #10.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 11531380 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED DUE TO SIGNIFICANT BONE LOSS AND INFECTION AT THE IMPLANT SITE. THE IMPLANT WAS REMOVED.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 11210521 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 7 WAS REMOVED DUE TO BONE LOSS. IMPLANT WAS REMOVED AND AREA GRAFTED. PATIENT TO RETURN AFTER HEALING FOR IMPLANT REPLACEMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, PAIN AND INFLAMMATION.

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 11173116 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BOPS4311 IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH SITE #29. SITE WAS GRAFTED PRIOR TO IMPLANT PLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 10626392 ↗