3i T3® BOET410Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868033257), received between Jul 27, 2020 and Mar 12, 2026 — classified as 24 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Device Damaged by Another Device

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 36 HAS DAMAGED THREADS AND THAT AN UNKNOWN ABUTMENT SCREW FRACTURED INSIDE THE IMPLANT. IMPLANT WAS REMOVED AND NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE. THIS REPORT REFERS TO DAMAGED THREADS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577959 ↗
• InjuryDec 11, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO ALLERGIC REACTION & INFECTION. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 23776862 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 44 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21934548 ↗
• InjuryDec 2, 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: Sinus Perforation

  MAUDE report 20817277 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS ALONG WITH A LOSS OF INTEGRATION IN TOOTH SITES 14 AND UNK OBSERVED DURING A VISIT FOR DISCOMFORT. WHEN LIFTING THE PROSTHESIS, THE IMPLANT COMES OUT AS WELL. SYMPTOMS: PAIN. THE PROCESS WAS COMPLETED WITH OTHER IMPLANTS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20703632 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2 IMPLANTS WERE REMOVED DUE TO BONE LOSS AT TOOTH LOCATION 44 AND 42.

  Patient problems: Osteolysis

  MAUDE report 20405444 ↗
• InjurySep 19, 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 20254702 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ONCE THE SURGICAL SITE OF TOOTH #24 WAS READY, THE SURGEON PICKED UP THE IMPLANT WITH THE DRIVER, WHICH THEN DISENGAGED ITSELF FROM THE DRIVER, THE SURGERY WAS COMPLETED USING ANOTHER IMPLANT. NO ADDITIONAL APPOINTMENT REQUIRED. NO SYMPTOMS AS A RESULT OF THE EVENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564624 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH #36. PATIENT SUFFERED INFLAMMATION. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18873318 ↗
• InjuryNov 30, 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 27 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18238401 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #41/42 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17052411 ↗
• InjuryJul 25, 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 AT THE SITE. THE PATIENT HAD AN APICAL ABSCESS AND PAIN AT THE SITE AND WILL RETURN FOR A NEW IMPLANT IN THE FUTURE.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 15097913 ↗
• InjuryJun 23, 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 AT THE SITE. THERE WAS POSSIBLE CONTAMINATION DUE TO PERIODONTITIS AT LOWER TEETH.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14788694 ↗
• InjuryApr 28, 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14236551 ↗
• InjuryApr 28, 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.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14236511 ↗
• MalfunctionApr 25, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE COVER SCREW DOES NOT SCREW INSIDE THE IMPLANT AND WAS REMOVED. ANOTHER IMPLANT HAS BEEN PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191777 ↗
• InjuryDec 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 12 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13038337 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT AN IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION COULD NOT BE PLACED BECAUSE IT DID NOT OBTAIN PRIMARY STABILITY. THE DOCTOR CONFIRMS THAT THE DENTAL SURGICAL PROCEDURE WAS NOT CONCLUDED WITH ANOTHER IMPLANT IN THE SAME SURGERY. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795904 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 21, 19 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 12439813 ↗
• MalfunctionAug 26, 2021Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369147 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES #46 AND #47 WERE UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY DURING THE SURGERY AND NO OTHER IMPLANT WAS PLACED AFTER THE FIRST ONES FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141513 ↗
• InjuryMay 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT FELT PAIN AT TOOTH LOCATION # 19 AND THE IMPLANT LACKED PRIMARY STABILITY AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11868049 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS UNABLE TO PLACE DUE TO A LACK OF PRIMARY STABILITY DURING THE SURGERY AND NO OTHER IMPLANT WAS PLACED AFTER THE FIRST ONE FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861665 ↗
• InjuryDec 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Abscess; Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 11002590 ↗
• InjuryOct 16, 2020Adverse 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. AS RESULT OF THE EVENT PATIENT HAD PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10689306 ↗