BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1518898 · Received October 29, 2009

    Report

    Report Number
    1030489-2009-01006
    Event Type
    Injury
    Date Received
    October 29, 2009
    Report Date
    September 29, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. FURTHER DETAILS ABOUT THE SCREWS ASSOCIATED WITH THIS EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6955508, WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT W05K1083 IS 10/26/2005; MFR DATE FOR LOT W05K1086 IS 12/02/2005. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WHO HAD BASILAR IMPRESSION ASSOCIATED WITH RHEUMATISM UNDERWENT A PROCEDURE AT O-C3 USING POSTERIOR FIXATION. IT WAS REPORTED THAT ALL THREE CORTICAL SCREWS FOR THE MIDLINE OC PLATE BACKED OUT. THE PATIENT REPORTEDLY DEVELOPED A MODEST NUMBNESS. A REVISION SURGERY WAS PERFORMED APPROXIMATELY FIVE WEEKS POST OP. DURING THE REMOVING PROCEDURE, IT WAS FOUND THAT THE MIDLINE OC PLATE WAS IMPLANTED NOT AT MIDLINE BUT TOWARD RIGHT. THE PLATE WAS REPLACED. THE SURGEON BELIEVED THAT THERE WAS NOT ANY PROBLEM RELATED TO THE IMPLANTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC. NA W05K1083

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention BONE SCREW CATALOG #: G6955508| LOT # W05K1083| LOT # W05K1086