BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHUS ORTHOPEDICS

    MDR report key: 889455 · Received August 2, 2007

    Report

    Report Number
    MW5003267
    Event Type
    Other
    Date Received
    August 2, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 22, 2007
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I AM A RESEARCH PATIENT WITH AN EXPERIMENTAL ARCHUS IMPLANT (SPINAL). I WAS TOLD BY MY PHYSICIAN DR THAT ORTHOPEDICS WOULD HEAR THE COST OF MEDICAL PROCEDURAL. I HAVE BEEN RECEIVING BILLS FROM THE HOSP WHERE THE SURGERY TOOK PLACE, AND SO DID MY INSURANCE CO. WHEN I CONTACTED CO, I WAS TOLD THAT THEY BILL OTHER SOURCES AS THEY DID WITH ME. THE QUESTIONNAIRE REGARDING CO IMPLANT IS TOTALLY INAPPROPRIATE AND DOES NOT ALLOW RESEARCH PATIENTS TO DESCRIBE THEIR EXPERIENCES FOLLOWING SURGERY. MY MEDICAL CONDITION WAS LEG TINGLING - NO BACK PAIN. THEIR QUESTIONNAIRE ONLY ADDRESSES BACK PAIN!!! DOSE OF AMOUNT: SURGERY. DATE OF USE: ONE DAY IN 2006, DIAGNOSIS OR REASON FOR USE: LEG MALFUNCTION. NOW I HAVE BACK PAIN. CONTACT: DR. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHUS ORTHOPEDICS ARCHUS JDN

    Patients

    Seq Age Sex Outcome Treatment
    1 6.5 YR Other