BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM

    MDR report key: 1193115 · Received October 6, 2008

    Report

    Report Number
    9617544-2008-00103
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODES WILL BE REPORTED ON A SUPPLEMENTAL, FOLLOWING THE ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SCREW HEADS LOCKED (LOST POLYAXIAL CAPABILITY) IN THE PATIENT. SCREWBACK COULDN'T BE BROKEN FREE IN THE PATIENT. SCREWS WERE REMOVED FROM PATIENT AND REPLACED. UPON TRYING TO BREAK THE HEAD FREE POST OPERATION, ONE SCREW HEAD COMPLETELY BROKE FREE. THE OTHER IS STILL LOCKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA A82000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other