NA 02.206.212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982050908), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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) 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/12MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13793199 ↗