BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1040447 · Received May 8, 2008

    Report

    Report Number
    1030489-2008-00230
    Event Type
    Injury
    Date Received
    May 8, 2008
    Report Date
    April 11, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWP
    PMA / PMN Number
    K003780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TOT HE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SURGICAL PROCEDURE, TO REMOVE THE CONGENITAL ENLARGED ODONTOID PROCESS IN 2008. THE SECOND SURGERY WAS PERFORMED TWO DAYS POST OP, TO IMPLANT THE POSTERIOR FIXATION AT OCCIPITAL TO C2. NO SCREWS WERE PLACED AT C1. APPROXIMATELY, TEN DAYS POST THE SECOND OPERATION, FOUR OCCIPITAL SCREWS BACKED OUT. THE THIRD SURGERY WAS PERFORMED APPROXIMATELY TWO WEEKS AFTER THE SECONDARY SURGERY TO REMOVE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC NA W05L0074

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention