3i T3® BOPT5415Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00844868029847), received between Dec 30, 2020 and Jul 29, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a peri-implantitis. Tooth location 26.Patient suffered from pain.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50066003 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #33. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22219214 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS AND PAIN ON TOOTH 13. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, REPLACEMENT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO. SITE GRAFTED: ALLOGRAFT WITH IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20735558 ↗
• 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 #23 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20565081 ↗
• 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 #24 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19232698 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #8, WITH ASSOCIATED INFLAMMATION DUE TO GUM TISSUE THAT NEVER HEALED PROPERLY. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18157053 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS, TOOTH #11. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18127854 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN TO DO ADDITIONAL BONE GRAFTING TO PRESERVE IMPLANT SITE 27 AND PROVIDE BONE SUPPORT. IMPLANT FAILED TO INTEGRATE. IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. SITE GRAFTED WITH XENOGRAFT TOGETHER WITH ORIGINAL PLACEMENT OF IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18124240 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAVING INFLAMMATION, INFECTION. TEETH NUMBERS #13 & #14. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18120569 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AREA AROUND THE IMPLANT AT TOOTH LOCATION #13 WAS INFLAMED WITH INFECTION AND BONE LOSS. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18093609 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ONGOING ISSUES SINCE IMPLANTS PLACEMENT. THE SITES WERE DEBRIDED, AND BONE LOSS WAS DISCOVERED. IT WAS DETERMINED THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANTS TOOTH SITES #6 AND 7, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED, AND THE AREA WAS BONE GRAFTED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17840986 ↗
• InjuryMay 17, 2021Adverse 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11834774 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH # 11 (UNIVERSAL), BOPT5415 WAS REMOVED DUE TO INFECTION & BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11404369 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 28 WAS PLACED ON (B)(6) 2020, ON (B)(6) 2020 DURING POST OP APPOINTMENT, PATIENT COMPLAINED OF SORENESS BUT WOUND LOOKED GOOD, RECOMMENDED RINSES AND HEAT TO JAW. PATIENT RETURNED ON (B)(6) 2020 WITH PAIN AND TENDERNESS BUCCALLY AND LINGUALLY. PROCEEDED TO EXPLANT # 28 DUE TO INFECTION. SITE GRAFTED. PATIENT TO RETURN IN 4 MONTHS FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, TENDERNESS, SWELLING, INFLAMMATION & PAIN.

  Patient problems: Inflammation; No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 11242935 ↗
• InjuryDec 30, 2020Adverse 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 AT TOOTH SITE #9.

  Patient problems: No Code Available

  MAUDE report 11097643 ↗