BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3954949 · Received July 24, 2014

    Report

    Report Number
    1030489-2014-03273
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART #G6950315, G6956418, G6956420, G7750015 AND G7752536. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL SPINAL FUSION AT C3-6. IT WAS REPORTED THAT 9 DAYS POST-OP, THE PATIENT WAS DIAGNOSED WITH A POST-OP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433894 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RODS, SCREWS, SETSCREWS, CONNECTOR