BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS FCD-2 DEVICE

    MDR report key: 3066373 · Received April 16, 2013

    Report

    Report Number
    2032499-2013-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 16, 2013
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K090767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SURGEON REPORTS IS DOING A REMOVAL BECAUSE HE THINKS SCREW IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163897 PERPOS FCD-2 DEVICE MRW INTERVENTIONAL SPINE, INC. 9062-00 / 9063-00 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention