TSX Implants TSX31B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868045014), received between Nov 11, 2023 and Nov 11, 2025 — classified as 11 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO IMPLANTS HAD FAILED AT THE PATIENT'S SURGICAL RELEASE AND WERE REMOVED. NOT SURE WHY THEY FAILED AND TOOTH LOCATIONS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526054 ↗
• InjurySep 8, 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 LOOSE AND WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22998019 ↗
• InjuryJul 12, 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 #24.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22488441 ↗
• InjuryMar 10, 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 #26 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 21568511 ↗
• InjuryFeb 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 #7 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21460835 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SINUS PERFORATION REPORTED. THEREFORE, THE IMPLANT WAS REMOVED. TOOTH NUMBER 6..

  Patient problems: Sinus Perforation

  MAUDE report 21337176 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A RECHECK FOLLOW UP ON THE IMPLANT AT TOOTH LOCATION #25. THE PATIENT HAD PAIN AND THE IMPLANT WAS LOOSE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19990917 ↗
• InjuryJun 18, 2024Adverse 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 #22 (UNIVERSAL).

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19557194 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS OBTAINED VIA EMAIL ON (B)(6) 2024, THE CLINICIAN REPORTED THAT THE EVENT WASN¿T A SINUS PERFORATION BUT A VESTIBULAR PERFORATION IN THE ANTERIOR SECTOR. IT WAS ALSO NOTED THAT DESPITE THE PRESENCE OF A SURGICAL GUIDE AND A CONE-BEAM COMPUTED TOMOGRAPHY (CBCT), BONE DENSITY AND VOLUME DO NOT DID NOT ALLOW HIM TO POSITION A 3.1 X 13 IMPLANT BUT A 3.1 X 11 IMPLANT.

  Patient problems: Perforation; Sinus Perforation

  MAUDE report 19151963 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION, TOOTH 25. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 18967999 ↗
• InjuryNov 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18116945 ↗