BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFERENCE 2 SPINE SYSTEM

    MDR report key: 1767668 · Received July 13, 2010

    Report

    Report Number
    3004744230-2010-00003
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Report Date
    July 12, 2010
    Manufacturer
    US SPINE
    Product Code
    MNH
    PMA / PMN Number
    K081296
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STILL AWAITING RETURN OF MEDICAL DEVICE, MORE EVALUATION WILL BE PROVIDED IN FOLLOW UP.

    Description of Event or Problem · 1

    RECEIVED X-RAY FROM UNITED STATES SPINE REPRESENTATIVE SHOWING A POLYAXIAL HEAD BODY HAVING SEPARATED FROM THE HEAD OF A PEDICLE SCREW AT THE S1 LEVEL. ADDITIONAL INFORMATION TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFERENCE 2 SPINE SYSTEM NONE MNH US SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention