3i T3® BOST411Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 00844868028932), received between Sep 26, 2019 and Aug 18, 2026 — classified as 218 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 223 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant, at Tooth site 14., was removed due to bone loss and infection with inflammation.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50294429 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to infection.

  Patient problems: Unspecified Infection

  MAUDE report 50276327 ↗
• InjuryJun 4, 2026Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 36 FRACTURED AFTER 7 YEARS IN PATIENT MOUTH. IMPLANT WAS LOADED. IMPLANT WAS REMOVED, BONE REGENERATION WAS PERFORMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389285 ↗
• 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 24963421 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIGNIFICANT BONE LOSS WAS NOTED AROUND THE IMPLANT AT TOOTH SITE #29. THE IMPLANT WAS REMOVED AND A BONE GRAFT WAS PLACED DUE TO INFECTION AND BONE LOSS. AN ADDITIONAL APPOINTMENT IS ANTICIPATED FOR AN IMPLANT REPLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24765988 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2.5 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24680164 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT TOOK ANTIBIOTICS BEFORE THE SURGERY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24389900 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 24338594 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT #10 FAILED, BUCCAL BONE FRACTURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24257083 ↗
• InjuryDec 17, 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 #1.5 WAS REMOVED DUE TO INFECTION AND BONE LOSS. DOCTOR REPORTED THAT THE PATIENT HAD ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 23831157 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IMPLANT WAS REMOVED DUE TO AN INFECTION AT TOOTH SITE #25. PATIENT SUFFERED AN ABSCESS AND SUPPURATION. A NEW IMPLANT WILL BE PLACED AFTER 2 MONTHS.

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

  MAUDE report 23736414 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23736225 ↗
• InjuryNov 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 #25 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23645415 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 AND #27 DEVELOPED INFECTION AND CAME OUT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23435635 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 AND #27 DEVELOPED INFECTION AND CAME OUT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23435572 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH WAS REMOVED DUE TO PERI-IMPLANTITIS. DETECTED EVIDENCE OF PERI-IMPLANTITIS AT A ROUTINE POST OP CLEANING. DETECTED LOOSENESS / NON-INTEGRATION OF IMPLANT SITE DURING A SURGICAL FLAP TREATMENT. IMPLANT WAS REMOVED & NEW IMPLANT PLACED INTO HEALTHY GONE AT ADJACENT SITE. THE SURGICAL FLAP TREATMENT WAS DONE ON THE REMOVAL DATE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22861192 ↗
• 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 THAT AN IMPLANT WAS REMOVED DUE TO AN ALLERGIC REACTION AND INFECTION AT TOOTH SITE 46. ABSCESS WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 22802188 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #23 WAS REMOVED AFTER 4,5 YEARS IN SITE DUE TO PERI-IMPLANTITIS. IMPLANT COULD BE EASILY REMOVED. PATIENT HAS BEEN RESCHEDULED FOR REIMPLANTATION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22329985 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #12. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22219690 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #13. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22218804 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #32. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22201384 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #21-23. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22201338 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FROM TOOTH SITE #15 WAS INTEGRATED AND IT WAS REMOVED DUE TO AN INFECTION. THE IMPLANT WAS INTEGRATED AND THE SURROUNDING AREA HAD GRANULATED. REGENERATIVE SURGERY WAS ATTEMPTED, BUT THERE WAS SO MUCH GRANULATION TISSUE THAT THE DECISION WAS MADE TO REMOVE THE IMPLANT. ANOTHER IMPLANT WILL BE PLACED AFTER REGENERATION.

  Patient problems: Unspecified Infection

  MAUDE report 22164961 ↗
• InjuryJun 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 LOCATION #5 WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22158940 ↗
• InjuryMay 22, 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 TRANSFER TO A FULL ARCH REHABILITATION CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073387 ↗