BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA BLOCKER

    MDR report key: 2097082 · Received May 2, 2011

    Report

    Report Number
    9617544-2011-00155
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K982494
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). K060361. 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

    IT WAS REPORTED THAT "DR. WAS DOING AN L5-S1 PARS REPAIR. HAD PEDICLE SCREW IN AT 5 AND HOOK IN AT S1. WAS FINAL TIGHTENING AND THE BLOCKER BROKE ON THE HOOK. HE WAS NOT ANYWHERE CLOSE TO 12NM YET WHEN BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA BLOCKER IMPLANT KWQ STRYKER SPINE BORDEAUX NA U26

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK