3i T3® BOPT4315Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00844868029908), received between Aug 6, 2020 and Apr 15, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #43 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24886317 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24886178 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT TOOK ANTIBIOTICS BEFORE THE SURGERY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24390215 ↗
• 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 #11 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22929842 ↗
• InjuryJun 20, 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 #11 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22296582 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #8 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA, INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19352264 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #24. PATIENT SUFFERED INFLAMMATION AND PAIN. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19082429 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT CAME IN FOR AN INFECTION CHECK APPOINTMENT. PATIENT PRESENTED FOR AN INFECTION/SWELLING IN SINUS POST-OPERATIVE APPOINTMENT. PATIENT WAS DIAGNOSED WITH AN INFECTION. PATIENT PRESENTED FOR SURGERY ON (B)(6) 2023 TO HAVE THE SITE DEBRIDED. IMPLANT #6 WAS REPLACED WITH A NEW ONE DURING DEBRIDEMENT AND BONE GRAFT PLACEMENT. SITE WAS DEBRIDED THEN #6 IMPLANT WAS REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 19055456 ↗
• 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 # 25 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 18924060 ↗
• InjuryMar 15, 2024Mechanical Problem; Mechanical Problem

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

  Patient problems: Pain

  MAUDE report 18916569 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS SEEN FOR A POST-OP AND THE SURGICAL SITE WAS SHOWING VISIBLE INFECTION AND DRAINAGE. THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18567192 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT SITE 5 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18422278 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18063093 ↗
• 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 IMPLANTS WERE REMOVED, AND THE AREA WAS BONE GRAFTED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17840999 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR NOTED 50% BONE LOSS WITH NO BONE AT THE FACIAL SURFACE SURROUNDING THE IMPLANT AT TOOTH LOCATION #7. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 17062950 ↗
• InjuryMay 11, 2023Adverse 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: Pain

  MAUDE report 16916139 ↗
• InjuryApr 26, 2023Adverse 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: Osteolysis; Unspecified Infection

  MAUDE report 16820944 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #25 FAILED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15908810 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT SITE 9 WAS REMOVED DUE TO TENDERNESS AND PAIN AT TIME OF UNCOVERING. THE IMPLANT WAS INTEGRATED. THE SITE WAS GRAFTED WITH ALLOGRAFT.

  Patient problems: Pain

  MAUDE report 15873626 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE # WAS REMOVED DUE A BONE PERFORATION AND INFECTION. SYMPTOMS OF THE EVENT: ABSCESS, SWELLING.

  Patient problems: Abscess; Swelling/ Edema; Unspecified Infection

  MAUDE report 15677073 ↗
• InjuryAug 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED PATIENT STATED THAT HER IMPLANT WAS CAUSING PAIN 24/7. AET TOOK PANOS CBCT SCANS TO CHECK IMPLANT MULTIPLE TIMES. - NOTHING WAS EVER WRONG WITH PATIENT'S IMPLANT. SHE SATED SHE BELIEVES SHE MAY BE ALLERGIC TO METAL OF IMPLANT. IMPLANTS WERE COMPLETELY INTEGRATED. TOOTH 15.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 15140242 ↗
• InjuryMay 7, 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 BONE LOSS NEAR THE GINGIVAL HEIGHT OF THE IMPLANT. THE IMPLANT WAS REMOVED IMPLANT AND PLACED A NEW ONE IN A DEEPER POSITION.

  Patient problems: Osteolysis

  MAUDE report 14315562 ↗
• InjuryFeb 2, 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 AN INFECTION WITH AN ABSCESS AT THE SITE. TOOTH #10.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 13423801 ↗
• InjurySep 21, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507761 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CALLED BECAUSE SHE WAS HAVING A LOT OF PAIN AND SWELLING A FEW DAYS AFTER THE PROCEDURE AT TOOTH LOCATION 15. WAS SEEN AT THE OFFICE THE NEXT DAY AND AS SOON AS THE DOCTOR APPLIED THE LOCAL ANESTHETIC INJECTION, THE AREA IMMEDIATELY BEGAN TO OOZE PUSS FROM THE INJECTION SITE. A SINUS LIFT ON IMPLANT WAS DONE. ON (B)(6) 2021 PATIENT CAME IN FOR EMERGENCY REMOVAL OF IMPLANT AND DRAINAGE OF INFECTION IN THE SINUS CAVITY WHERE THE IMPLANT AND BONE GRAFTING WAS DONE. A BIOPSY OF THE SITE WAS SENT TO PATHOLOGY LAB FOR ANALYSIS. FOLLOW UP AS NEEDED TO MONITOR HEALING. PROCEDURE WAS NOT COMPLETED USING OTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFECTION, INFLAMMATION, PUSS, SWELLING & PAIN.

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

  MAUDE report 11835642 ↗