BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9959184 · Received April 14, 2020

    Report

    Report Number
    1030489-2020-00456
    Event Type
    Injury
    Date Received
    April 14, 2020
    Date of Event
    March 23, 2020
    Report Date
    April 14, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: BONE FRACTURE. PMA/510K: THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 6958720, 510K# K143471 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420415 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5510846

    Patients

    Seq Age Sex Outcome Treatment
    1 Other