BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS AND INTERNAL FIXATOR

    MDR report key: 6510796 · Received April 19, 2017

    Report

    Report Number
    MW5069240
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 1, 2017
    Report Date
    April 19, 2017
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD SURGERY TO IMPLANT A DEVICE ONTO THE BONES IN MY ELBOW TO HOLD THEM IN PLACE AND CORRECT A BREAK. BUT WHEN IT WAS REMOVED THEY FOUND THAT THE DEVICE WAS NOT ONLY BROKEN BUT IT HAD NOT WORKED AND SAID THERE WAS NO WAY IT COULD HAVE BEEN BROKEN BY MYSELF OR BY THEM WHEN THEY PUT IT IN. MY DOCTOR SAID HE SENT THE DEVICE TO THE MANUFACTURER TO FIND OUT WHAT THE PROBLEM WAS. BUT HE HAD ALREADY ASKED IF I WANTED THE DEVICE AFTER THE SURGERY AND I SAID I WANTED IT, BUT HE SENT IT OFF ANYWAY WITHOUT MY KNOWLEDGE, AND DIDN'T TELL ME UNTIL AFTERWARDS. IT IS CALLED A SKELETAL DYNAMICS INTERNAL FIXATOR. AT MY APPOINTMENT YESTERDAY, I FOUND OUT I HAVE TO HAVE SURGERY AGAIN TO REPAIR MY ELBOW. I AM IN A GREAT DEAL OF PAIN AND CANNOT USE MY ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285217 SKELETAL DYNAMICS AND INTERNAL FIXATOR PROSTHESIS HRS SKELETAL DYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention