BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1805129 · Received August 13, 2010

    Report

    Report Number
    1030489-2010-01057
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 22, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    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

    (B)(4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT #0025947W AND 0031318W. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #6900240, 510K #K003780 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0025947W IS 05/11/2009. THE MANUFACTURE DATE FOR LOT 0031318W IS 06/05/2009. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT:| PEDICLE SCREWS:| IMPLANT:| SET SCREWS:| EXPLANT:| CROSSLINK:| IMPLANT: