3i T3® BOST585Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00844868029694), received between Dec 3, 2019 and Dec 11, 2025 — classified as 56 injuries, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 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 23783746 ↗
• MalfunctionDec 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DOCTOR TRIED TO PLACE THE IMPLANT, HOWEVER THE INSIDE THREADS WERE DAMAGED AND THE TORQUE WRENCH DID NOT LOCK INTO THE IMPLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777798 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT AN INFECTION AT TOOTH SITE #3. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 22891483 ↗
• InjuryAug 25, 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 #3 WAS REMOVED DUE TO INFECTION. PATIENT HAD SIGNS OF INFECTION AT ONE WEEK FOLLOW-UP APPOINTMENT AFTER BEING ON ANTIBIOTICS POST-OPERATION. PATIENT WAS SEEN FOR ONE WEEK FOLLOW-UPS FOR THE NEXT THREE WEEKS WITH CONTINUED ANTIBIOTICS EACH WEEK. PARULIS NOTED ON BUCCAL. SURGICALLY EXPLORED IMPLANT AND COMPLETE PERI-IMPLANTITIS WAS NOTED. GRANULATION TISSUE COMPLETELY SURROUNDED THE IMPLANT. IMPLANT WAS LOOSE WITH NO BONY CONTACT. REMOVED THE FAILED IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22891171 ↗
• InjuryJul 11, 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. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478284 ↗
• InjuryJul 11, 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS PLACED THEN 2 MONTHS LATER FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22478115 ↗
• InjuryJun 14, 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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED EDEMA, INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22208367 ↗
• InjuryMay 21, 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 # 26.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22065707 ↗
• 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 #35 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22047505 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SINUS PERFORATION AT TOOTH SITE 26. ONE MONTH AFTER THE SURGERY, THE PATIENT PRESENTED SINUSITIS. X-RAYS WERE TAKEN AND IT WAS FOUND THAT THE MAXILLARY SINUS WAS OCCUPIED. AN ADDITIONAL APPOINTMENT WAS REQUIRED FOR EXPLANTATION AND IMPLANT REPLACEMENT.

  Patient problems: Sinus Perforation

  MAUDE report 21717500 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOST OF INTEGRATION DUE TO A PERIIMPLANTITIS AT TOOTH SITE #46. IMPLANT WAS COMPLETELY REMOVED. NO IMPACT ON THE PATIENT REPORTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21595736 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21266859 ↗
• InjuryJan 21, 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 IMPLANTITISAT TOOTH LOCATION 47. PAIN REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21195553 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED DUE TO BONE LOSS AND INFECTION. TOOTH #19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20053838 ↗
• 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 19970683 ↗
• 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 19970274 ↗
• 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 19970249 ↗
• 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 19970229 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT #17 SPONTANEOUSLY EJECTED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19772598 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH PAIN AROUND THE IMPLANT AT TOOTH LOCATION# 14. A 3D IMAGE SHOWED SINUS INFECTION, THEREFORE THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19580154 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #2 WAS REMOVED DUE PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19562269 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED PAR ON IMPLANT INDICATING INFECTION. IMPLANT REMOVED. TOOTH #30 (UNIVERSAL).

  Patient problems: Unspecified Infection

  MAUDE report 19557010 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #24 (FDI) WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19324131 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MALE PATIENT OF 54 YEARS OLD CAME TO THE CLINIC 4,5 YEARS LATER STARTED TO FEEL DISCOMFORT IN TOOTH LOCATION 26. IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN + INFLAMMATION. PATIENT WILL RETURN TO REGENERATE THE BONE AND TO TRY ANOTHER IMPLANT.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 18873278 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT REMOVED DUE TO BONE LOSS. TOOTH #31.

  Patient problems: Osteolysis

  MAUDE report 18707811 ↗