BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO PROFILE TWO-LEVEL ACP SIZE 28MM

    MDR report key: 1210157 · Received October 20, 2008

    Report

    Report Number
    9617544-2008-00130
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K063430
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE SCREW WAS BEING DRIVEN ONE SIDE OF THE LOCKING RING RAISED ABOVE THE PLATE SURFACE. THE SURGEON LEFT THE PLATE IN PLACE BUT REMOVED THE LOCKING RING AND FINISHED DRIVING THE SCREW. FURTHER, THE SURGEON EXACTLY FOLLOWED THE SURGICAL TECHNIQUE BY USING A DRILL-GUIDE. NO OTHER CONSEQUENCE OR DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO PROFILE TWO-LEVEL ACP SIZE 28MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA 080841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other