BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINAL SCREWS

    MDR report key: 4945910 · Received July 22, 2015

    Report

    Report Number
    MW5044813
    Event Type
    Other
    Date Received
    July 22, 2015
    Date of Event
    July 12, 2001
    Report Date
    July 22, 2015
    Manufacturer
    SPINAL SOLUTIONS LLC
    Product Code
    MNI
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IN A MOTORCYCLE ACCIDENT AND MY NECK WAS BROKEN C-6 AND C-7 WERE FUSED. I JUST READ THAT THERE IS A RECALL ON SCREWS (HARDWARE) FROM A COMPANY CALLED SPINAL SOLUTIONS LLC. I HAVE MOVED SEVERAL TIMES AND HAVE A DIFFERENT LAST NAME NOW, SO IF THERE WAS AN ATTEMPT TO CONTACT ME BY LETTER ABOUT THE RECALL, I DID NOT RECEIVED IT. MY NAME AT THE TIME OF ACCIDENT WAS (B)(6). THE FUSION WAS DONE AT SHOCK TRAUMA IN BALTIMORE (B)(6) 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475430 SPINAL SCREWS SPINAL SCREWS MNI SPINAL SOLUTIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR