BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSP PEDICLE SCREW

    MDR report key: 955441 · Received November 30, 2007

    Report

    Report Number
    1526439-2007-00357
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    April 24, 2007
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HWC
    PMA / PMN Number
    K860017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME, THESE TYPES OF EVENTS ARE TYPICALLY CAUSED BY OVER-TIGHTENING THE SCREW DURING INSERTION, OR BY TIGHTENING THE NUT ONTO THE SCREW AT AN OBLIQUE ANGLE.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT THREE SCREWS WERE BROKEN DURING TIGHTENING OF THE NUT ONTO THE MACHINE THREAD. THIS RESULTED IN A DELAY TO THE CASE. AS THE DELAY WAS IN EXCESS OF 30-MIN AN MDR IS BEING FILED TO DOCUMENT THIS EVENT. DEVICE 1 SEE ALSO 1526439-2007-000358, 1526439-2007-00359.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP PEDICLE SCREW FIXATION DEVICE HWC DEPUY SPINE, INC. NA ACBBC1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR