3i T3® BOPT5413Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00844868029830), received between Dec 9, 2019 and Jan 6, 2026 — classified as 39 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO INFECTION. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 23980944 ↗
• InjurySep 2, 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 # 5 FAILED AND WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22946021 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. TOOTH SITE: 19SYMPTOMS: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21980377 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. MAXILLARY DIEM CASE (B)(6) 2022. IMPLANT IN FUNCTION FOR TWO YEARS. BONE LOSS, SEVERE NOTED (B)(6) 2024, IMPLANT REMOVED AND SITE GRAFTED. PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE.

  Patient problems: Osteolysis

  MAUDE report 20923011 ↗
• InjuryAug 23, 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 #20 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20052764 ↗
• InjuryAug 23, 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 HAD INFECTION. PATIENT HAD PAIN. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & SWELLING.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 20052070 ↗
• InjuryAug 20, 2024Adverse 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 20002487 ↗
• InjuryAug 9, 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 #12 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN & SWELLING.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 19955374 ↗
• InjuryJun 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 SITE #30 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19632985 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS (AUGMENTIN) FOR 7 DAYS FOR INFECTION PRIOR TO IMPLANT REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 19629198 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EARLY ONSET INFECTION / PAIN 10 DAYS POST IMPLANT PLACEMENT. TOOTH #29. THE IMPLANT WAS REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19358704 ↗
• MalfunctionMay 16, 2024Mechanical Problem; Mechanical Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330211 ↗
• 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19231378 ↗
• 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 # 23 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19231296 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE # 30 WAS REMOVED WHEN PT RETURNED TO OFFICE FOR STABILITY CHECK AND PERI-IMPLANTITIS WAS NOTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18926272 ↗
• InjuryJan 10, 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 32 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18482612 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND A LOOSE FEELING AROUND THE IMPLANTS AT TOOTH LOCATIONS #8 AND #9. THE IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18101154 ↗
• InjuryNov 9, 2023Adverse 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; Pain; Unspecified Infection

  MAUDE report 18100720 ↗
• InjuryOct 6, 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 PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. PATIENT HAD TO RETURN TO COMPLETE THE PROCEDURE.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17884645 ↗
• InjuryMay 4, 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 #13 (UNIVERSAL) WAS REMOVED DUE TO BONE LOSS. PATIENT HAS DEVELOPED BONE LOSS ON THE APEX OF THE IMPLANT. THREADS ARE VISIBLE. IMPLANT WAS REMOVED AND BONE GRAFT (XENOGRAFT) WAS PLACED. GRAFTED TOGETHER WITH ORIGINAL IMPLANT PLACEMENT AS WELL. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN, AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16868043 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED IN THE MEDICAL CENTRE FOR PERI-IMPLANTITIS, REMOVAL OF IMPLANTS 30.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16498759 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED IN THE MEDICAL CENTRE FOR PERI-IMPLANTITIS, REMOVAL OF IMPLANTS 29.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 16498642 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED LOSS OF BUCCAL CORTICAL PLATE AND COPIOUS GRANULATION TISSUE. NOTED INFECTION AT IMPLANT PLACEMENT SITE. 2 MONTHS AFTER PLACEMENT GRANULATION TISSUE NOTICED AROUND APICAL ASPECT OF IMPLANT AT TIME OF UNCOVERING. IMPLANT WAS REMOVED AND SITE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, AND INFLAMMATION. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT. TOOTH SITE # 30 UNIVERSAL.

  Patient problems: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16194290 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED NERVE INJURY. THERE HAD BEEN AN EXTRACTION OF 36 SOME 2 WEEKS BEFORE, WHEN REMOVAL OF 46 BECAME NECESSARY. SUGGESTED PLACEMENT OF IMMEDIATE IMPLANT 46 SITE AND EARLY IMPLANT 36 SITE. TOOTH SITE # 36. PARESTHESIA WAS REPORTED AS A SYMPTOM.

  Patient problems: Nerve Damage; Paresthesia

  MAUDE report 15566049 ↗
• InjurySep 30, 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. CURETAGE HAS BEEN MADE. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15518765 ↗