BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3093999 · Received May 6, 2013

    Report

    Report Number
    0009617544-2013-00167
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    November 30, 2012
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THAT 3 SCREWS FAILED DURING A SURGERY. IT IS REPORTED THAT THREE SCREWS BROKE DURING A SURGERY WHEN THE SURGEON TRIED TO ATTACH THE ROD AND THEY WERE CHANGED. WITHOUT INSPECTION OF THE INVOLVED IMPLANTS, IT IS IMPOSSIBLE TO DETERMINE THE FAILURE MODE AND FAILURE CAUSE. NO CORRECTIVE ACTIONS CAN BE APPLIED IN CURRENT CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A STRYKER SALES REP THAT "... WHILST IN THEATRE THAT THEY HAD HAD ISSUES WITH SPINE SCREWS AND THEREFORE CHANGED TO A DIFFERENT PROVIDER (DEPUEY/SYNTHE). IT IS REPORTED THAT THREE SCREWS BROKE IN SURGERY WHEN TRYING TO ATTACH THE ROD AND THIS IS WHY THEY CHANGED. NOTE: THIS INFORMATION WAS OBTAINED WHILST THE SALES REP WAS DISCUSSING HIS PRODUCTS WITH THE NURSE AND WAS NOT REPORTED WHEN THE INITIAL INCIDENT HAPPENED. STRYKER ONLY BECAME AWARE OF THIS TODAY WHEN THE REP VISITED THE HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196328 UNKNOWN_SPINE_PRODUCT IMPLANT KWQ STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1