BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARRINGTON RODS

    MDR report key: 1726750 · Received June 13, 2010

    Report

    Report Number
    MW5016352
    Event Type
    Injury
    Date Received
    June 13, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 13, 2010
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLEASE, YOU MUST STOP ALL PHYSICIANS/SURGEONS FROM USING HARRINGTON RODS OR ANY TYPE OF HARDWARE FOR SCOLIOSIS PTS. MY DAUGHTER IS (B) (6) AND WHEN SHE WAS (B) (6), SHE WAS DIAGNOSED WITH SCOLIOSIS AND HER SPINE WAS TURNING, GATHERING HER LUNGS AND HEART. THE PHYSICIAN ASSURED US THAT AFTER THE RODS ARE IN PLACE, HER SPINE WILL ALWAYS BE STRAIGHT AND SHE CAN DO ANYTHING SHE WANTS, EXCEPT SKYDIVING. HE NEVER ONCE TOLD US THAT THESE RODS HAVE A HISTORY OF BREAKING AND/OR THE HARDWARE WILL BREAK WHICH LEADS TO FURTHER HEALTH PROBLEMS. IT HAS BEEN 10 YEARS AND HER RODS BROKE AWAY FROM HER SPINE, HER NECK IS INVERTED AND HER SPINE IS BACK TO A QUESTION SHAPE MARK. NOW MY DAUGHTER HAS TO UNDERGO ANOTHER SURGERY TO REMOVE THE RODS AND WE DON'T KNOW WHAT TO DO AFTER TO CORRECT HER SCOLIOSIS. DATES OF USE: (B) (6) 2000 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: SEVERE SCOLIOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARRINGTON RODS HARRINGTON RODS HSB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| R