BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1521010 · Received October 30, 2009

    Report

    Report Number
    1030489-2009-01031
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    October 5, 2009
    Report Date
    October 5, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6955724, 510K# K042789 WAS CLEARED IN THE UNITED STATES. THE IMPLANT REMAINS IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE AT THIS TIME. THERE IS NO FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.

    Description of Event or Problem · 1

    IT WAS FOUND APPROX TWO AND A HALF MONTHS POST OP THAT C2 SCREW BROKE AFTER THE POSTERIOR FIXATION FROM OCCIPUT TO T1. THE PT REPORTEDLY WAS ASYMPTOMATIC, THE REVISION SURGERY IS NOT PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM BONE SCREW KWQ WARSAW ORTHOPEDIC INC. NA W07E5454

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR