BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONCSTRUCTION SYSTEM

    MDR report key: 1259226 · Received December 4, 2008

    Report

    Report Number
    1030489-2008-00646
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    WARSAW ORTHOPEDICS INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # W07H1772 AND # W07H1773. DEVICE HISTORY RECORDS FOR BOTH LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6900240, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE AT OCCIPITAL-C4 USING POSTERIOR FIXATION. AT AN UNKNOWN TIME POST-OP, THE ROD AROUND OCCIPITAL-C2 WAS BROKEN. THE FUSION REPORTEDLY WAS NOT COMPLETED. THE REVISION SURGERY TO REPLACE THE ROD WAS PERFORMED APPROXIMATELY 10 MONTHS POST OP. IT WAS REPORTED THAT THE CROSSLINK AND THE WIRING WERE ADDED TO THE FIXATION AT THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONCSTRUCTION SYSTEM ROD KWQ WARSAW ORTHOPEDICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention