3i T3® BOPT6513Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00844868029878), received between Nov 26, 2019 and Mar 18, 2026 — classified as 21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS VERTICAL BONE LOSS ON THE DISTAL OF THE IMPLANT AT TOOTH SITE # 15 AND THAT THE IMPLANT HAD FAILED. THE IMPLANT WAS REMOVED AND AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis

  MAUDE report 24630856 ↗
• InjuryApr 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21756379 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT OVERLOADING WAS SUSPECTED AT THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19644715 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18093364 ↗
• InjuryFeb 9, 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 16342197 ↗
• InjuryNov 8, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection

  MAUDE report 15751630 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED SEVERE PERI-IMPLANTITIS WITH CHRONIC INFECTION AND BONE LOSS. REQUIRED REMOVAL. INFLAMMATION IS REPORTED AS A SYMPTOM. TOOTH SITE # 30 (UNIVERSAL).

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 14105940 ↗
• InjuryFeb 10, 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 WITH PAIN, INFLAMMATION AND IMPLANT MOBILITY.

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

  MAUDE report 13507388 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856132 ↗
• InjuryOct 17, 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 AND GETTING CLOSE TO THE NERVE. NO NERVE INJURY REPORTED. TOOTH #18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643987 ↗
• InjurySep 28, 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 BONE LOSS. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12541466 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT PRESENTED WITH 50 PER CENT BONE LOSS AROUND THE IMPLANT. THE IMPLANT WAS NOT MOBILE AND THE SITE WAS BONE GRAFTED AND PATIENT SENT HOME TO HEAL. TOOTH SITE # 19 (UNIVERSAL).

  Patient problems: Osteolysis

  MAUDE report 12537581 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 11631379 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS PERI-IMPLANTITIS. NO BUCCAL BONE. IMPLANT BOPT6513 AT TOOTH SITE #18 WAS REMOVED AND SITE GRAFTED WITH ALLOGRAFT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11384926 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT # 4 WAS REMOVED DUE TO INFECTION. ADDITIONAL APPOINTMENTS / IMPLANT RE-PLACEMENT: NOT INDICATED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11285200 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT(S) AT TOOTH SITE #14 WAS UNABLE TO BE PLACED IN THE OSTEOTOMY AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 11151830 ↗
• InjuryNov 6, 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 AT THE IMPLANT SITE #30. PATIENT WILL RETURN FOR A NEW IMPLANT IN 4 MONTHS.

  Patient problems: No Information

  MAUDE report 10805140 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # UNKNOWN WAS UNABLE TO PLACE IN OSTEOTOMY AND WAS REMOVED.

  Patient problems: No Information

  MAUDE report 10771416 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THE BOPT6513 IMPLANT IN SITE #19 WAS REMOVED DUE TO INFECTION. IMPLANT HAD DEVELOPED A CHRONIC DRAINING FISTULA. PATIENT WILL NOT RETURN FOR AN ADDITIONAL PROCEDURE TO REPLACE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 10638010 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 30 WAS REMOVED DUE TO INFECTION AND BONE LOSS. PATIENT TO RETURN FOR FUTURE RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, BONE LOSS, ABSCESS, INFLAMMATION AND PAIN.

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

  MAUDE report 10257430 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION WITH AN ABSCESS. AS A RESULT, THE IMPLANT WAS REMOVED FROM TOOTH SITE 19.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9376609 ↗