BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM VLIFT INSERTER

    MDR report key: 2031196 · Received March 17, 2011

    Report

    Report Number
    9617544-2011-00104
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 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
    MI, 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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE HANDLE ON THE INSIDE SHAFT OF A CUSTOM VLIFT INSERTER BROKE OFF. IT MADE IT IMPOSSIBLE TO INSERT AND EXPAND THE CAGE. WE HAD TO REMOVE THE CAGE FROM THE PATIENT, AND PLACE THE CAGE ON A DIFFERENT INSERTER."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR