BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICK''X

    MDR report key: 2968220 · Received February 19, 2013

    Report

    Report Number
    2520274-2013-01033
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    January 19, 2010
    Manufacturer
    SYNTHES (USA) WEST CHESTER, PA
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT AND NO FURTHER INVESTIGATION CAN BE PERFORMED. ACTUAL EVENT DATE NOT KNOWN. EXACT PART NUMBER COULD NOT BE IDENTIFIED. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE KWQ, MNH, MNI AND NKB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLICK X MONO SCREW BROKE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72086 CLICK''X CLICK''X SCREW KWP SYNTHES (USA) WEST CHESTER, PA

    Patients

    Seq Age Sex Outcome Treatment
    1