BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 2792357 · Received October 12, 2012

    Report

    Report Number
    9617544-2012-00439
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ¿HARDWARE REMOVAL DUE TO ROD PULL OUT AND FAILURE OF BLOCKERS. PATIENT IS NON SYMPTOMATIC.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM BLOCKER IMPLANT NKB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R (B)(4)| XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM