BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1181749 · Received September 18, 2008

    Report

    Report Number
    1030489-2008-00519
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWP
    PMA / PMN Number
    K042922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT REMAINS IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE. THREE MONTHS POST-OP X-RAY WAS REVIEWED. THE FILM REVEALS THE LATERAL VIEW OF CERVICAL CONSTRUCT FROM ACDF C3-C6. THE BONE SCREW AT C6 APPEARS SLIGHTLY BACKED OUT. NO IMMEDIATE POST-OP FILMS ARE AVAILABLE TO NOTE MIGRATION OR INITIAL POSITION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACDF AT C3-C6 USING ANTERIOR FIXATION. ONE OF THE CAUDEL SCREWS BACKED OUT APPROXIMATELY THREE MONTHS POST-OP. NO REVISION SURGERY IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM PLATE KWP WARSAW ORTHOPEDIC INC NA W07L4038

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR