3i T3® BOSS310Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00844868028758), received between Dec 18, 2019 and Jan 16, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #44 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24100434 ↗
• InjuryJun 26, 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 PERI-IMPLANTITIS. PATIENT SUFFERED PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22335401 ↗
• InjuryMay 21, 2025Adverse 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. PATIENT EXPERIENCING SWELLING A WEEK AFTER PLACING IMPLANTS SENT PATIENT FOR 3D AND ORAL SURGEON RECOMMENDED REMOVING IMPLANT. IMPLANT REMOVED SITE GRAFTED. WILL PLACE NEW IMPLANTS IN 6 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22065312 ↗
• InjuryApr 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS AT TOOTH SITES 34/36 OBSERVED DURING THE CLINICAL PROCEDURE. SYMPTOMS REPORTED ON THE PATIENT: PAIN, INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21915515 ↗
• InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THA THTE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION 14.PAIN REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20873608 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824605 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 12 AND 14 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 15432319 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 14 AND 16 WERE REMOVED DUE TO BONE LOSS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 15431941 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 14 AND 16 WERE REMOVED DUE TO BONE LOSS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 15431439 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 24 AND 26 WERE REMOVED DUE TO BONE LOSS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 15430650 ↗
• InjuryAug 29, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN. TOOTH SITE #24.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 15314485 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY DURING IMPLANT PLACEMENT. DOCTOR DID NOT COMPLETE THE PROCEDURE PLACING OTHER IMPLANT. A NEW IMPLANT WILL BE PLACED AFTER AUGMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134634 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE BOSS310 IMPLANT TORQUE TESTED WELL WHEN EXPOSED ON (B)(6) 2020. PATIENT COMPLAINED OF PAIN IN LATE (B)(6). PATIENT DEVELOPED FISTULA ON FACIAL AND HAD CRESTAL BONE LOSS ON REMOVAL. ABSCESS AND DEHISCENCE IS ALSO NOTED. TOOTH SITE # 10. SITE WAS GRAFTED AND PATIENT SENT HOME TO HEAL.

  Patient problems: Abscess; Fistula; Osteolysis; Pain; Unspecified Infection

  MAUDE report 11467604 ↗
• InjuryDec 18, 2019Adverse 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: Unspecified Infection

  MAUDE report 9487253 ↗