BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR STANDARD SCREW 6.0X31MM

    MDR report key: 2770206 · Received October 1, 2012

    Report

    Report Number
    9617544-2012-00416
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K073437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION. THE OTHER THOR SCREW REFERENCED IN THE EVENT DESCRIPTION WILL BE REPORTED WITH REPORT # 9617544-2012-00417.

    Description of Event or Problem · 1

    AS STATED "THE PATIENT HAD "THOR" IMPLANTED FOR AN L5-S1 ALIF. MONTHS PAST THE SURGERY, THE S1 SCREWS BROKE. THE PATIENT IS FUSED AND IS NOT EXPERIENCING ANY PAIN OR DISCOMFORT FROM THE INCIDENT. SURGEON MOST LIKELY WILL NOT TAKE OUT THE PLATE OR THE SCREWS. S1 SCREWS BROKE: 2, (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THOR STANDARD SCREW 6.0X31MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK