BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2062293 · Received March 18, 2011

    Report

    Report Number
    9617544-2011-00105
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 21, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS COSTUMER STATE: "INSTRUMENT WAS USED TO REMOVE A SCREW WHEN THE INSTRUMENT WAS TURNED, THE DISTAL PART OF THE INNER BROKE INSIDE THE SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 109521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK