BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2241038 · Received September 9, 2011

    Report

    Report Number
    1030489-2011-01147
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 BY THE PATIENT THAT THE PATIENT UNDERWENT A CERVICAL SURGICAL PROCEDURE. IT WAS REPORTED THAT ONE MONTH POST-OP THE PATIENT EXPERIENCED PAIN IN THE RIGHT ARM AND THAT THE PAIN HAS MOVED INTO THE LEFT ARM ALSO. THE PATIENT REPORTED THAT THE PAIN IS NOT ALLOWING THE PATIENT TO SLEEP MORE THAN HALF AN HOUR AT THE TIME. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCREWS