BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2883193 · Received December 21, 2012

    Report

    Report Number
    1030489-2012-02924
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 2, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# G6959428, LOT H11J2360; PART #G6959430, LOT H11J1746; PART G6959432, LOT H11J1747; LOT H11K0273. (B)(4): THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6959428, 6959430, 6959432, 510K # K081297 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H11J2360 IS 10/19/2011; THE MANUFACTURE DATE FOR LOT H11J1746 IS 10/12/2011; THE MANUFACTURE DATE FOR LOT H11J1747 IS 10/06/2011; THE MANUFACTURE DATE FOR LOT H11K0273 IS 10/27/2011. 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.

    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 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention