BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALOGIC

    MDR report key: 2172629 · Received July 19, 2011

    Report

    Report Number
    2020737-2011-00006
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 19, 2011
    Manufacturer
    DJO GLOBAL
    Product Code
    LOF
    PMA / PMN Number
    P910066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT STATES THAT THE UNIT IS CAUSING WEAKNESS IN HIS LEGS. PT STATED THAT HE CONTACTED HIS DOCTOR AND THAT THE DOCTOR SAID, IT WAS NORMAL AND TO CONTINUE TREATMENT. DOCTOR WILL BE CONTACTED TO VERIFY IF IT WAS NORMAL AFTER SURGERY OR FOR THE UNIT TO CAUSE WEAKNESS. NO OTHER INFO PROVIDED OR CONFIRMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINALOGIC BONE GROWTH STIMULATOR LOF DJO GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other