BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH 3DX SPINAL SYSTEM

    MDR report key: 2446021 · Received February 7, 2012

    Report

    Report Number
    MW5024168
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    November 23, 2009
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, I HAD A SPINAL FUSION AT THE (B)(6) HOSPITAL. APPROX TWO WEEKS LATER, X-RAYS REVEALED THE BOTTOM TWO TSRH SCREWS DECOUPLED FROM THE TSRH RODS. I ASKED, AT THIS TIME, TO HAVE THE SURGERY REDONE, AND WAS TOLD TO TAKE A WAIT AND SEE APPROACH. I WAS ALSO TOLD THE BREAKOFF MALFUNCTIONED AND A NEW ONE WAS QUICKLY INVENTED FOR ALL FUTURE PATIENTS. AFTER FEELING BETTER THROUGH THE HEALING PROCESS, I GOT TO A POINT WHERE I PEAKED AND WENT DOWN HILL FROM THERE. IT IS NOW AT A POINT I CAN'T SLEEP AND THE SURGERY IS GOING TO BE REDONE IN TWO WEEKS. I HAVE ASKED FOR AN MDR TO BE COMPLETED WITH THE FDA, I HAVE NOT HEARD IF THIS HAS BEEN DONE. I AM SENDING A COPY OF THIS INFO TO THE FDA TO ENSURE IT IS FOLLOWED UP ON. DATES OF USE: (B)(6) 2009 - PRESENT. DIAGNOSIS: SPINAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH 3DX SPINAL SYSTEM TSRH SCREWS AND RODS, CONNECTORS, HEX KWP MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R| S