BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 2915330 · Received January 9, 2013

    Report

    Report Number
    9617544-2013-90012
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, THIS WILL BE REPORTED AS SUPPLEMENTAL.

    Description of Event or Problem · 1

    THE VIGILANCE RESPONSIBLE OF THE HOSPITAL, (B)(6), REPORTED VIA FAX AN EVENT OF BREAKAGE OF THE PEDUNCULAR SCREW AT L5 LEVEL LEFT PEDUNCLE, WITH CONSEQUENT LOOSENING OF THE RIGHT L2 BLOCKER AND CAUDAL MIGRATION AND LOOSENING OF LEFT L2 BLOCKER. THE PT UNDERWENT A SURGICAL PROCEDURE OF FIXATION OF L2-L3-L4-L5 WITH A XIA 3 SYSTEM ON (B)(6) 2011 DUE TO A MIELINIC FRACTURE AT L4 LEVEL. ON 6TH OF DECEMBER 2012 THE PT UNDERWENT A UNANTICIPATED REVISION SURGERY IN WHICH ALL THE XIA 3 IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11730 XIA 3 TITANIUM BLOCKER IMPLANT KWP STRYKER SPINE BORDEAUX NA RDY

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR