BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULLY THREADED CANCELLOUS SCREW

    MDR report key: 3874376 · Received April 18, 2014

    Report

    Report Number
    2648920-2014-00094
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ZIMMER
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREWS APPEAR TO BE 14MM IN LENGTH INSTEAD OF THE 20MM IN LENGTH THEY SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238061 FULLY THREADED CANCELLOUS SCREW HWC ZIMMER 62629432

    Patients

    Seq Age Sex Outcome Treatment
    1 FULLY THREADED CANCELLOUS SCREW,| CATALOG #00484002000, LOT #62629432, QUANTITY - 21