BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ROD

    MDR report key: 3932522 · Received July 14, 2014

    Report

    Report Number
    1030489-2014-03239
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MNI
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN "POSTERIOR FIXATION AT LEVELS T12 TO L3 BECAUSE OF L2 BURST FRACTURE. THE VERTEBRAE L2 WAS LOST 40% HEIGHT AND THE BONE FRAGMENT WAS 50% INSIDE THE CENTRAL CANAL. PATIENT WAS EXPERIENCING HARD PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409176 UNKNOWN ROD MNI MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR