BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 2152300 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00215
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "XIA 4.5 ROD EXTENDER SMALL WAS FOUND TO BE BROKEN DURING A ROUTINE LENGTHENING PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL IMPLANT NKB STRYKER SPINE BORDEAUX NA 07E138

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR