BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 5359707 · Received January 12, 2016

    Report

    Report Number
    1030489-2016-00145
    Event Type
    Injury
    Date Received
    January 12, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7750510, 510K # K062879 WAS CLEARED IN THE UNITED STATES. WE DO NOT HAVE ANY IMAGING FILMS. HENCE, THE CAUSE THAT CONTRIBUTED TO THE INCIDENT CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION FOR C7 FRACTURE AT C5-TH2. INTRA-OP, TRANSARTICULAR SCREWS WERE INSERTED AT C5/6, C6/7, C7/TH1 BUT POST-OP, IT WAS FOUND THAT THE PLACED SCREW DEVIATED TO SPINAL CANAL DIRECTION. REVISION WAS PERFORMED FOR RE-INSERTION ON THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19402 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention