BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URS Ø5 L45

    MDR report key: 2960653 · Received February 14, 2013

    Report

    Report Number
    2520274-2013-00918
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    December 17, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) REPORTED A SCREW WAS LOOSE AFTER INSERTION. THE SCREW WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65064 URS Ø5 L45 URS Ø5 L45 KWP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1