3i T3® BOST513Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868029670), received between May 29, 2019 and Aug 17, 2026 — classified as 26 injuries, 1 malfunction.

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 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with a loose implant at tooth site 36 and pain. The implant was removed due to peri-implantitis and inflammation. A new implant will be placed after healing.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50274801 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558556 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THE SURGICAL CLINIC FOR EVALUATION OF THE IMPLANT AT TOOTH SITE #22. THE IMPLANT WAS NOTED HAVING SIGNIFICANT BONE LOSS AND WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 24512560 ↗
• InjuryJul 11, 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, AT TOOTH SITE #46.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22478188 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION AT TOOTH SITE #36. IMPLANT WAS COMPLETELY REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21616538 ↗
• InjuryMay 3, 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 #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19238913 ↗
• InjuryDec 28, 2023Adverse 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 BONE LOSS AROUND IMPLANT, AT SECOND STAGE TIME FRAME. TOOTH #29.

  Patient problems: Osteolysis

  MAUDE report 18416203 ↗
• 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 18326180 ↗
• 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 18326074 ↗
• InjuryApr 21, 2023Adverse 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: Dizziness; Headache; Pain

  MAUDE report 16786569 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS WAS DISCOVERED AROUND THE IMPLANT AT TOOTH LOCATION #13 DURING THE UNCOVERING VISIT. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 16762460 ↗
• InjuryApr 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Fistula; Purulent Discharge; Unspecified Infection

  MAUDE report 16705321 ↗
• MalfunctionAug 5, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS PLACING THE THIRD PARTY RESTORATIVE ABUTMENT, HE COULD NOT GET IT TO SEAT FULLY BECAUSE OF DAMAGE TO THE IIMPLANT'S INTERNAL HEX CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176327 ↗
• InjuryMay 13, 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 AND BONE LOSS. PATIENT WILL RETURN FOR A REPLACEMENT IMPLANT. TOOTH #13.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14402381 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION # 14. THERE WAS PROGRESSIVE BUCCAL BONE LOSS LENDING TO CHRONIC INFECTION. CUSTOMER DIDN'T USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE. SYMPTOMS: ABSCESS AND INFLAMMATION WERE REPORTED. PATIENT WONT RETURN FOR AN ADDITIONAL APPOINTMENT.

  Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 14322877 ↗
• InjuryFeb 10, 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. TOOTH SITE # 5.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 13506867 ↗
• InjuryFeb 4, 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 WITH PAIN AND INFLAMMATION AT THE SITE. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 13451370 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO A LACK OF PRIMARY STABILITY. MULTIPLE SIZES WERE ATTEMPTED AT THE SITE. TOOTH #3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865061 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITE 22.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12710506 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY. THE AREA WAS GRAFTED AND THE PATIENT IS RETURNING IN 3 MONTHS FOR IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698957 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 9 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 12618909 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY WITH THE BOST513 IMPLANT. PAIN IS REPORTED AS A CONSEQUENCE. TOOTH SITE # 11.

  Patient problems: Pain

  MAUDE report 11901050 ↗
• InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS THEY HAVE AN IMPLANT AT TOOTH LOCATION #11 THAT HAS DEVELOPED INFECTION. SITE GRAFTED AFTER IMPLANT REMOVAL. PATIENT WILL RETURN IN 4 MONTHS TO REPLACE.

  Patient problems: Unspecified Infection

  MAUDE report 11426563 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A SIGNIFICANT INFECTION 4 WEEKS POST OP. IMPLANT WAS REMOVED AND SITE WAS GRAFTED. PAIN, EDEMA AND INFLAMMATION WERE ALSO NOTED. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #30.

  Patient problems: Edema; Inflammation; Pain; Unspecified Infection

  MAUDE report 10691460 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BOST513) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 30. CLINICIAN NOTED INFECTION IN THE INFERIOR BORDER OF THE IMPLANT. IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 10378591 ↗