NA 241.37Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982166883), received between Feb 13, 2020 and Dec 3, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THAT HWR + REVISION RADIUS + ULNA PROCEDURE WAS PERFORMED. REVISION PLATING WAS DONE FOR NON-UNION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23703526 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, A PATIENT HAD FULL BODY RASH WHICH BEGAN AFTER AN ANKLE FRACTURE REPAIR WITH ONE (1) 3.5 MM LCP ONE-THIRD TUBULAR PLATE AND EIGHT (8) 3.5 MM CORTEX SCREWS. ALLERGY TESTING HAS CONFIRMED THE PATIENT IS ALLERGIC TO INDIUM (III) CHLORIDE, A COMPOUND FOUND IN SOME METAL ALLOYS WHICH MAYBE OF THE IMPLANTS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/85MM. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13793126 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 1 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705697 ↗