BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLIFT EXPANDER

    MDR report key: 1900160 · Received October 22, 2010

    Report

    Report Number
    9617544-2010-00421
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 4, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NURSE (B)(6) REPORTED, VIA SALES REP (B)(6), THAT THE INNER SHAFT BROKE OFF WHILE THE SURGEON TRIED TO SCREW THE CAGE ON. THE SURGEON COULD FINISH THE OPERATION WITHOUT ANY CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VLIFT EXPANDER INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 080966

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK