BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK TITANIUM CAGE

    MDR report key: 288552 · Received August 4, 2000

    Report

    Report Number
    MW1019437
    Event Type
    Injury
    Date Received
    August 4, 2000
    Date of Event
    September 30, 1997
    Report Date
    August 4, 2000
    Manufacturer
    SPINE TECH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FAILURE OF FUSION REQUIRING REMOVAL OF CAGE AND PLACEMENT OF PLATES AND SCREWS. RPTR NOW HAS INCREASED PAIN AND VERY LIMITED RANGE OF MOTION. RPTR IS PROHIBITED FROM SITTING, STANDING, WALKING OR BENDING. HAS NOT BEEN ABLE TO WORK FOR FIVE YEARS. HOLES FOR BONE GROWTH WERE TOO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK TITANIUM CAGE TITANIUM FUSION CAGE MAX SPINE TECH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability