TSX Implants TSX6B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868045298), received between May 13, 2024 and Mar 13, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BONE FRACTURE INHIBITED PLACEMENT OF THE IMPLANT AT TOOTH SITE #19. BONE GRAFTING WAS PLACED AT THE SITE.

  Patient problems: Bone Fracture(s)

  MAUDE report 24593827 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24420969 ↗
• MalfunctionMar 18, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE IMPLANT WAS MISSING FROM THE VIAL. THE IMPLANT AND THE LITTLE POST WAS MISSING. THE ISSUE WAS FOUND DURING A PROCEDURE BUT HAD ANOTHER IMPLANT AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629794 ↗
• MalfunctionJan 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO THE HEX BEING STRIPPED. HAD TO REMOVE IT AND USE ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169986 ↗
• InjuryOct 16, 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 #18 WAS LOOSE DURING A DENTIST VISIT. THE IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20463560 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SEVERE BONE LOSS, PERI-IMPLANTITIS, TOOTH 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION, BONE LOSS.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19297367 ↗