BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACF DISTRACTION SCREWS 14MM, S

    MDR report key: 903485 · Received August 22, 2007

    Report

    Report Number
    2430952-2007-00026
    Event Type
    Injury
    Date Received
    August 22, 2007
    Report Date
    August 22, 2007
    Manufacturer
    INSTRUMED INTERNATIONAL INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE END OF THE DEVICE BROKE OFF LEAVING A PORTION OF THE SCREW IN THE PEDICLE OF THE PATIENT. THE PHYSICIAN HAD TO REMOVE THE PIECE WITH A NEEDLE HOLDER. THERE WAS NO DELAY IN PROCEDURE. NO EXCESSIVE FORCE WAS USED ON THE SCREW. THE PIECES WERE DISCARDED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACF DISTRACTION SCREWS 14MM, S SURGICAL INSTRUMENT LXH INSTRUMED INTERNATIONAL INC. * 390071

    Patients

    Seq Age Sex Outcome Treatment
    1 *