BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON MODULAR PEDICLE SCREW SYSTEM

    MDR report key: 2882085 · Received November 9, 2012

    Report

    Report Number
    3008524126-2012-00028
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    July 14, 2011
    Report Date
    November 9, 2012
    Manufacturer
    ORTHOFIX INC.
    Product Code
    HWC
    PMA / PMN Number
    K042514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON INFORMATION PROVIDED, X-RAYS WERE TAKEN AND THE SET SCREW WAS FOUND TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON MODULAR PEDICLE SCREW SYSTEM SET SCREW HWC ORTHOFIX INC. 54-2001 (9)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other