BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/CAGE

    MDR report key: 406803 · Received July 17, 2002

    Report

    Report Number
    MW4003312
    Event Type
    Injury
    Date Received
    July 17, 2002
    Date of Event
    January 1, 1998
    Report Date
    July 17, 2002
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER SEVERAL UNSUCCESSFUL SURGERIES RELATED TO HERNIATED DISK, PT RECEIVED A PROCEDURE WHERE A MEDICAL DEVICE CALLED "BAK/CAGE" WAS INSERTED IN L4/L5 AREA OF BACK. PT RELATES THAT PRIOR TO THE SURGERY THEY WERE 15% IMPAIRED AND PT IS NOW 100% IMPAIRED. IN ADDITION TO THE BELOW SYMPTOMS PT IS ALSO CONCERNED THAT THEY WERE NOT INFORMED THAT THEY WERE THE FIRST AND ONLY PT THAT THE DR HAD PERFORMED THIS PROCEDURE ON, THAT THE DEVICE WAS NOT APPROVED UNTIL 2001 AND THEIR SURGERY WAS PERFORMED IN 1998 AND THAT THEY MAY HAVE BEEN INVOLVED IN A CASE STUDY WITHOUT THEIR CONSENT. COMPLAINANT CLAIMS THE PHYSICIAN ASSURED THEM THAT AFTER THE SURGERY THEY WOULD BE 100% BETTER. A LAWYER HAS BEEN RETAINED. COMPLAINT SYMPTOMS: CHANGE IN SENSATION (NUMBNESS, TINGLING) SPASMS IN LEFT LEG, LOCALIZED PAIN AND TENDERNESS, CHANGE IN GROWTH PATTERNS, CONSTANT CHRONIC PAIN AND HUNCH BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/CAGE SPINAL FIXATION MAX SULZER SPINE-TECH NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Disability