NA 204.848Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982146434), received between Feb 5, 2018 and Feb 5, 2018 — 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.

• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2016, PATIENT UNDERWENT SURGERY TO TREAT A LEFT ANKLE FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 2.7MM/3.5MM LCP LATERAL DISTAL PLATE AND TEN (10) SCREWS. IT WAS UNKNOWN TO THE SURGEON IF THE PATIENT WAS ALLERGIC TO METAL AT THE TIME OF THE INITIAL SURGERY. SUBSEQUENTLY THE PATIENT FELT SOME SOFT TISSUE IRRITATION AND THIS WAS DISCOVERED TO BE A REACTION TO METAL ALLERGY. THE SURGEON THEN DECIDED TO REMOVE ALL IMPLANTED DEVICES AND THE CONSTRUCT WITH ALL DEVICES INTACT WAS REMOVED ON (B)(6) 2018. INTRA-OPERATIVE X-RAYS TAKEN SUGGESTED THAT THE FRACTURE HAD COMPLETELY HEALED. THE REMOVAL OF PLATE AND SCREWS CONSTRUCT WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED AND THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 48MM THIS IS REPORT 7 OF 11 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7242059 ↗