BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL PEDICLE SCREW 7.5 X 50

    MDR report key: 1111695 · Received August 13, 2008

    Report

    Report Number
    1649384-2008-00425
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT, PRIOR TO SURGERY, IT WAS NOTICED THAT THE SCREW HEAD WAS NOT ATTACHED. THE MALFUNCTION OF A SIMILAR DEVICE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL PEDICLE SCREW 7.5 X 50 PATHFINDER MNI ABBOTT SPINE 37PF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK