3i T3® BOPS4310Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00844868028390), received between Dec 12, 2019 and May 11, 2026 — classified as 25 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 25 WAS REMOVED DUE TO AN INFECTION. THE DOCTOR CONFIRMED THAT THE IMPLANT WAS MOBILE AND INFECTED. A BIO-OSS (GEISTLICH) BONE GRAFT HAD BEEN PLACED EARLIER, BUT IT ONLY HEALED PARTIALLY, LEAVING SOME PARTICLES INSIDE GRANULATION TISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 25134878 ↗
• InjuryJan 7, 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 24 WAS REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21089614 ↗
• InjuryDec 7, 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 PERI-IMPLANTITIS AT TOOTH LOCATION 36. PAIN AND ABCESS WERE REPORTED AS A CONSEQUENCE OF THE EVENT. SITE WAS SURGICAL DESINFECTED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20873615 ↗
• InjuryAug 30, 2024Mechanical Problem; Mechanical Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20112569 ↗
• InjuryApr 22, 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 INFECTION. TOOTH # 23. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19160614 ↗
• InjuryMar 25, 2024Adverse 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; Unspecified Infection

  MAUDE report 18967560 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ACCUTE INFECTION. BOTH IMPLANTS REMOVED.TOOTH LOCATION 32 AND UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371848 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ACCUTE INFECTION. BOTH IMPLANTS REMOVED.TOOTH LOCATION 32 AND UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371791 ↗
• InjuryOct 19, 2023Adverse 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 IMPLANT TOOTH SITE #29. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17963754 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON FOLLOW UP, NOTED LOSS OF BONE - REMOVED AND NEW IMPLANT WAS PLACED. TOOTH #10.

  Patient problems: Osteolysis

  MAUDE report 17558390 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, UPON FOLLOW UP, NOTED LOSS OF BONE AND IMPLANT WAS REMOVED. NEW IMPLANT WILL BE PLACED. TOOTH #13.

  Patient problems: Osteolysis

  MAUDE report 17558229 ↗
• InjuryFeb 13, 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 #8 LOST INTEGRATION AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. INADEQUATE ORAL HYGIENE.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16363173 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 14 WAS REMOVED DUE TO AN INFECTION ON THE IMPLANT BED.

  Patient problems: Unspecified Infection

  MAUDE report 14040736 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 13 WAS REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14040618 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PRESENTED AN INFECTION ON THE IMPLANT SITE AND WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 14020480 ↗
• InjuryMar 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. TOOTH LOCATION # 11 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13722978 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED LACK OF PRIMARY STABILITY AT TOOTH SITES 24, 26. NO OTHER IMPLANTS WERE PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787018 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED LACK OF PRIMARY STABILITY AT TOOTH SITES 24, 26. NO OTHER IMPLANTS WERE PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786963 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 8 DID NOT ACHIEVE PRIMARY STABILITY DURING PLACEMENT AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770110 ↗
• InjuryNov 1, 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 BONE LOSS AND INFECTION. DID SITE PREPARATION AT THE TIME OF EXTRACTION.

  Patient problems: Abscess; Osteolysis; Unspecified Infection; Wound Dehiscence

  MAUDE report 12726943 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT LACKED PRIMARY STABILITY AT TOOTH SITE 27. NO OTHER IMPLANT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567380 ↗
• InjuryNov 2, 2020Adverse 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: Inflammation; No Information; Pain; Unspecified Infection

  MAUDE report 10770067 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BOPS4310 IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH SITE #30.

  Patient problems: No Code Available

  MAUDE report 10690344 ↗
• InjuryAug 3, 2020Adverse 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10356268 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT REMOVED DUE TO LACK OF PRIMARY STABILITY. NO OTHER IMPLANT WAS PLACED DURING THE SAME SURGERY.

  Patient problems: No Information

  MAUDE report 9456501 ↗