BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK CAGE

    MDR report key: 552509 · Received September 14, 2004

    Report

    Report Number
    MW1033123
    Event Type
    Injury
    Date Received
    September 14, 2004
    Date of Event
    August 7, 2000
    Report Date
    September 14, 2004
    Manufacturer
    ZIMMER CORP.
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD A SERIOUS ROAD TRAFFIC ACCIDENT IN 1996, HAD BRUISED RIBS WITH BACK PAIN THAT WAS LATER DIAGNOSED AS FIBROMYALGIA. PT CONSULTED AN ORTHOPEDIC SURGEON IN 2000. DEGENERATIVE DISC (L5S1) WAS SUSPECTED. PT WAS REFERRED AND OPERATED UPON IN 2000. SINCE THEN PT HAD LOST WEIGHT. PT HAS HAD DIARRHEA, BLOODY STOOL ALONG THE WAY, AND WAS GIVEN FLAGYL. CLOSTRIDIUM DIFFICILE WAS CULTURED. THE PAIN, HOWEVER, PERSISTED AND PT HAD ANOTHER SURGERY WHERE RODS AND SCREWS WERE IMPLANTED. PT IS DISABLED AND IS NOW ON SPINAL CORD STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK CAGE BAK CAGE MAX ZIMMER CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR LT CAGE 2002.