BEUDAMED
    FDA Adverse Event Other Summary report: N

    TITANIUM DISC

    MDR report key: 3242716 · Received July 19, 2013

    Report

    Report Number
    MW5030967
    Event Type
    Other
    Date Received
    July 19, 2013
    Date of Event
    December 20, 2010
    Report Date
    July 19, 2013
    Manufacturer
    NUVASIVE
    Product Code
    MJO
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT HE HAD A BACK INJURY IN THE L4/L5 AND WAS IMPLANTED A TITANIUM DISC. BEFORE SURGERY HE WAS TAKING A MUSCLE RELAXANT TO RELIEVE PAIN. THE ATTENDING SURGEON WAS DR (B)(6), DURING SURGERY A MACHINE BY NUVASIVE CALLED NUVASIVE NEUROVISION JJB MONITORING SYSTEM WAS USED (A MACHINE TO DETECT NERVE RESPONSE). AS ADVISED BY DR (B)(6) HE TOOK HIS MUSCLE RELAXANT BEFORE SURGERY. THE REPORTER LATER FOUND OUT HE SHOULD NOT HAVE TAKEN THE MEDICATION AS IT CONTRAINDICATES THE NEUROVISION JJB NEURO MONITORING SYSTEM. EVER SINCE THE SURGERY HE HAS NERVE PAIN THAT WOULD NOT GO AWAY AND RADIATES DOWN HIS LEGS AND UNABLE TO WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338052 TITANIUM DISC NONE MJO NUVASIVE NUVA LTDR 0701
    338053 NEUROVISION JJB MONITORING SYSTEM JJB ETN NUVASIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR