BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTEX SCREW

    MDR report key: 4852610 · Received June 17, 2015

    Report

    Report Number
    4852610
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NONUNION OF TALAR NECK FRACTURE, A BROKEN SCREW WAS FOUND ON RADIOGRAPH AND REMOVED A PORTION OF SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395601 CORTEX SCREW SCREW, FIXATION, BONE HWC SYNTHES (USA) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR THERE WERE OTHER IMPLANTED SCREWS