BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1181721 · Received September 17, 2008

    Report

    Report Number
    1030489-2008-00515
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 19, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN EXPLANTED, SO PRODUCT EVALUATION IS NOT POSSIBLE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE USING POSTERIOR FIXATION AT C1/2 FOR ODONTOID POSTERIOR PSEUDOTUMOR AT UNKNOWN DATE IN 2005. IT WAS CONFIRMED THAT THE SCREWS ON BOTH SIDES AT C1 WERE BROKEN. THE REVISION SURGERY WAS NOT SCHEDULED, BECAUSE THE PATIENT IS AN ELDERLY FEMALE, AND SHE WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC. NA W05K1640

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR