BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-00951

    MDR report key: 2963084 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00951
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE EXACT PART NUMBER COULD NOT BE IDENTIFIED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE WAS NOT RETURNED TO MANUFACTURING. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. 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

    EU COMPLAINT HANDLING UNIT REPORTED IT WAS DIFFICULT TO INSERT AN ORACLE PLATE. THE LEFT ILIAC VEIN WAS AT THE LEVEL OF DISC L4-5 VENTRALY. THIS WAS THE REASON FOR IMPLANTING ONLY THREE SCREWS. THE FOURTH SCREW, ANTERIOR AT L5, WAS NOT IMPLANTED BECAUSE IT WAS DANGEROUS AND COULD CAUSE VEIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69256 KWQ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1