BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY ANGLED V-LIFT EXPANDER

    MDR report key: 1931234 · Received November 11, 2010

    Report

    Report Number
    9617544-2010-00446
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 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
    FL, US
    Reporter Occupation
    OTHER

    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 EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THREADED TIP OF CUSTOM VISIT INSERTER BROKE OFF INSIDE OF VLIFT CAGE ATTACHMENT HOLE WHILE DISTRACTING CAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY ANGLED V-LIFT EXPANDER INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 14143

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR