BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II PERSUADER

    MDR report key: 1931748 · Received November 22, 2010

    Report

    Report Number
    9617544-2010-00467
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 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

    ADD'L 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 MRS (B)(6) REPORTED VIA SALES REP (B)(6), THAT WHILE PREPARATION PRIOR TO A SURGERY, THE HEAD WAS DRESSED TO SIZE. NO FURTHER INFO WERE GIVEN, THE HEAD OF THE DEVICE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II PERSUADER INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 04C360

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK