BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEGIS SELF TAPPING BONE SCREW, 28MM

    MDR report key: 1046057 · Received May 16, 2008

    Report

    Report Number
    1526439-2008-00109
    Event Type
    Injury
    Date Received
    May 16, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K052546
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE. LIMITED INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL (SIGNIFICANT) INFO BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SURGEON REPORTED, POST-OP BENDING OF AN AEGIS SCREW. SURGEON IS TAKING NO ACTION AT THIS TIME. IMAGES SENT TO DEPUY SPINE FOR EVALUATION. 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 AEGIS SELF TAPPING BONE SCREW, 28MM FIXATION DEVICE KWP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention