BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAGLE SCREW, 16MM

    MDR report key: 1150417 · Received September 5, 2008

    Report

    Report Number
    1526439-2008-00159
    Event Type
    Injury
    Date Received
    September 5, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K040197
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE AT THIS TIME. THE PROCESS OF SCREW FIXATION IS TECHNIQUE SENSITIVE, AND CARE MUST BE TAKEN TO ENSURE THAT THE SCREWS ARE PROPERLY ANGLED AND FULLY TIGHTENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON NOTED THAT AN EAGLE SCREW HAD BACKED OUT (SLIGHTLY) FROM THE PLATE. HE REPORTS THAT THE SCREWS HAVE EXCELLENT BONE PURCHASE AND THE PATIENT IS ASYMPTOMATIC. SURGEON IS TAKING NO ACTION AT THIS TIME. HE WILL MONITOR THE PATIENT. AS AN EVENT OF THIS NATURE COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE SCREW, 16MM CERVICAL FIXATION DEVICE KWQ DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention