BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3790257 · Received May 5, 2014

    Report

    Report Number
    1030489-2014-02402
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 6, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. SOMETIME POST-OP THE PATIENT REPORTED EXPERIENCING PAIN. THE PATIENT HAD A PAIN PUMP INSTALLED BUT IT DID NOT RELIEVE THE PAIN. THE PATIENT STATED THAT SHE IS SUFFERING FROM FLAT BACK SYNDROME CAUSED BY THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267737 UNK NEK MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other