3i T3® BOST511Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00844868029663), received between Aug 30, 2019 and Jan 7, 2026 — classified as 69 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  DURING THE INVESTIGATION PROCESS, ADDITIONAL INFORMATION WAS PROVIDED ON 05-MAR-2026 WHICH REPORTED THAT A BONE FISSURE WAS OBSERVED ON THE BUCCAL SIDE MESIALLY TO THE IMPLANT SITE OF THE LOWER LEFT OF TOOTH SITE #6, REVEALING EXPOSED THREADS. THE CAUSE WAS UNCLEAR AND AN INTERVENTION AT THAT POINT WAS NOT FEASIBLE. GIVEN THE ISQ VALUES (BUCCAL 78, LINGUAL 76, MESIAL 78, DISTAL 76), OSSEOINTEGRATION WAS DEEMED PRESENT, AND THE SECONDARY SURGERY PROCEEDED. A 6MM HEALING ABUTMENT WAS SEATED AT 20N TORQUE AND SUTURED WITH 3 STITCHES. AS OF DECEMBER 19, THE PATIENT HAD NOT BEEN INFORMED OF THE CRACK.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995516 ↗
• InjuryNov 25, 2025Adverse 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

  MAUDE report 23647921 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE #26. IMPLANT WAS COMPLETELY REMOVED. NO IMPACT ON THE PATIENT REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22910703 ↗
• InjuryAug 14, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN IMPLANT WAS REMOVED DUE TO AN ALLERGIC REACTION AT TOOTH SITE 36 . DOCTOR ALSO INDICATED INFECTION. ABSCESS WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 22802144 ↗
• InjuryJul 18, 2025Adverse 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 SITE #47. PATIENT SUFFERED PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22546427 ↗
• InjuryMay 16, 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: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22035890 ↗
• InjuryMar 27, 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 #31 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis

  MAUDE report 21710461 ↗
• InjuryMar 6, 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 #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21536208 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. IMPLANT DISPLACED, SIZE WILL BE DEBRIDED, BONE GRAFT WILL BE PLACED AND ANOTHER IMPLANT WILL BE PLACED. TOOTH 14. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION, BONE LOSS. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20732010 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED CROWN WAS LOOSE, BUT IT WAS IMPLANT. IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REPORTED CROWN WAS SORE WHEN CHEWING, PA TAKEN, BONE LOSS REPORTED, REMOVED IMPLANT AND GRAFTED WITH PUROS - BONE. TOOTH NUMBER 19. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVED IMPLANT. ADDITIONAL APPOINTMENT REQUIRED: YES, REPLACE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20731881 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 17 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT CAME IRREGULARLY FOR CONTROL CHECK UP.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20704139 ↗
• InjurySep 30, 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; Pain; Unspecified Infection

  MAUDE report 20332892 ↗
• InjuryAug 13, 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 19970645 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 45 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19926498 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19926471 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 22 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19793720 ↗
• InjuryJul 15, 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: Pain

  MAUDE report 19738270 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH LOOSE IMPLANT #13 WITH SORENESS WHEN PLACING / REMOVING DENTURE. THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19101516 ↗
• InjuryApr 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 14 WAS REMOVED DUE TO INFECTION. NO IMPACT TO PATIENT, NO MEDICAL HISTORY REPORTED. SITE GRAFTED WITH ALLOGRAFT.

  Patient problems: Unspecified Infection

  MAUDE report 19056521 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 31 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. PATIENT ARRIVED FOR STABILITY TEST AND THE IMPLANT HAD NOT INTEGRATED. SYMPTOMS AS A RESULT OF THE EVENT: SLIGHT SENSITIVITY.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18837368 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #19. IT WAS REPORTED PATIENT DEVELOPED SWELLING AND PAIN WITH RADIOGRAPH EVIDENCE OF INFECTION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18537917 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324257 ↗
• InjuryNov 18, 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/ABSCESS AT IMPLANT TOOTH SITE #14, WITH LOCALIZED SWELLING AND PAIN. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18166525 ↗
• InjuryAug 4, 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 #20 EXHIBITED BONE LOSS AND GENERAL RECESSION. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17461238 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TISSUE GROW OVER INFECTION OF THE IMPLANT SITE AT TOOTH LOCATION #26. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17458144 ↗