BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRABSORB PROSTHETIC CAGE

    MDR report key: 1411977 · Received June 24, 2009

    Report

    Report Number
    MW5011825
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    July 6, 2005
    Report Date
    June 24, 2009
    Manufacturer
    UNKNOWN
    Product Code
    OJB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I HAD A SPINAL FUSION AT L4-5 USING HYDRABSORB PROSTHESETIC CAGE AND DANEK M8 PEDICLE SCREWS AND RODS. POST OPERATIVELY I DID FINE UNTIL I STARTED HAVING PAIN IN NOVEMBER OF SAME YEAR, IN FEBRUARY I REQUESTED X-RAY WHICH SHOWED HYDRABSORB HAD DISSOLVED AS WELL AS THE COMPLETE FUSION USING MY ILIAC CREST AD CADAVER BONE. SCREWS DID NOT HOLD UP AND L4-5 HAD COLLAPSED AND COMPACTED ON EACH OTHER. I MENTALLY COULD NOT GO THROUGH SURGERY UNTIL 2008, BECAUSE MY LEGS GOT SO WEAK I COULDN'T GO UP STAIRS OR DO NORMAL DAILY ACTIVITIES, AS WELL AS CONSTANT PAIN AND DEPRESSION. I HAD TO APPLY FOR DISABILITY WHICH EVENTUALLY WAS APPROVED. I AM A RN AND INITIALLY I WENT BACK TO WORK UNTIL I FOUND OUT THE FUSION HAD COLLAPSED, SO MY PLANS TO CONTINUE WORKING ENDED. WHEN I HAD SECOND SURGERY. PHYSICIAN STATED THAT HYDRABSORB WAS AN INFERIOR PRODUCT AND HADN'T BEEN USED FOR A LONG TIME. I COULD MISUNDERSTOOD, BUT I WOULD LIKE THIS PRODUCT INVESTIGATED AS IT HAS CHANGED MY LIFE CAUSING ME A SECOND SERIOUS SURGERY FROM ANTERIOR AND POSTERIOR APPROACH AND I STILL HAVE PAIN. I DO HAVE MEDICAL SCREWS THAT WERE USED, BUT NO INFO ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRABSORB PROSTHETIC CAGE HYDRABSORB OJB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention| S