3i T3® BOPT4310Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00844868028468), received between Oct 25, 2019 and Sep 29, 2026 — classified as 132 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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. 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 139 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fracture

  Doctor reported the implant was removed due to a fracture, the abutment became loose and could not be adjusted due to the damage in the implant connection.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929497 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WENT INTO SINUS. THE DOCTOR WAS ABLE TO RETRIEVE THE IMPLANT FROM THE SINUS.

  Patient problems: Sinus Perforation

  MAUDE report 25414718 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO A PERI-IMPLANTITIS. THE PREVIOUS INTERVENTION HAD BEEN NORMAL, WITH A TORQUE OF 40 N, AND THE IMPLANT WAS MOBILE DURING THE PROCEDURE ON SEPTEMBER 17. THE MOBILITY OF THE REMOVED IMPLANT, TAKEN OUT WITHOUT ANESTHESIA ON (B)(6) 2024 WAS NOTED. NO IMPACT ON THE PATIENT WAS REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25230675 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24963870 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO AN INFECTION. PATIENT SUFFERED FROM PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24963496 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO A BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24887553 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #24 AND #25 WERE REMOVED AFTER THE PROSTHETIC RESTORATION DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24835038 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 5 IMPLANTS WERE PLACED IN OCT 2025. DURING SECOND SURGERY IN JANUARY TOOTH LOCATION #46 AND #36 HAD MOBILITY AND #36 HAD SUPPURATION. IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24388629 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANT INSTALLED AT TOOTH SITE #8, AND ADDITIONAL BONE WAS GRAFTED AT THE SITE. THREE MONTHS AFTER THE IMPLANT PROCEDURE THE PATIENT PRESENTED COMPLAINING THAT SOFT TISSUE AROUND THE IMPLANT DID NOT SEEM TO BE HEALING AND THAT THE GUMS HAD RECEDED AROUND THE IMPLANT. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REMOVE THE IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23978103 ↗
• MalfunctionDec 4, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714990 ↗
• 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 #22 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22946373 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEVERE HEALTH ISSUES GOING ON SO FAILURE WAS EXPECTED. THE IMPLANT AT TOOTH SITE #28 FAILED AND WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 22685797 ↗
• InjuryJul 17, 2025Adverse 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 22530480 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A TWO (2) WEEK FOLLOW UP AFTER BEING PRESCRIBED ANTIBIOTICS (AUGMENTIN) FOR 10 DAYS DUE TO THE SINUS FLUID LEVEL AND PAIN AROUND THE IMPLANT AT TOOTH LOCATION #4. THE SYMPTOMS WERE NOT RESOLVED; THEREFORE THE IMPLANT WAS REMOVED.

  Patient problems: Pain

  MAUDE report 22529852 ↗
• InjuryMay 23, 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 #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT PLACED ON (B)(6) 2024, PATIENT STATES THROBBING OCCURRED AND DURING AN EVALUATION, A RADIOLUCENCY WAS OBSERVED ON THE RADIOGRAPH. IMPLANT WAS REMOVED AND SITE WAS BONE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PULSATING/THROBBING & ERYTHEMA PRESENT, RADIOLUCENCY.

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

  MAUDE report 22080704 ↗
• InjuryMay 19, 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 #17 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22047639 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22026712 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO BONE RESORPTION.

  Patient problems: Osteolysis

  MAUDE report 21983538 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3.5 WEEKS AFTER PLACEMENT, THE IMPLANT AT TOOTH LOCATION #7 WAS MOBILE WITH LARGE BONE/TISSUE DEHISCENCE AND ABSCESS AT THE BUCCAL. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND DEHISCENCE.

  Patient problems: Unspecified Infection

  MAUDE report 21918496 ↗
• 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 # 20 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21754029 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN, DISCOMFORT, AND INFECTION AROUND THE IMPLANT AT TOOTH LOCATION #13. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21739979 ↗
• InjuryFeb 18, 2025Adverse 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 21401006 ↗
• InjuryFeb 18, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21398022 ↗
• InjuryFeb 18, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21392265 ↗
• InjuryFeb 12, 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 #4 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21365671 ↗