BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 409772 · Received August 7, 2002

    Report

    Report Number
    1526439-2002-00052
    Event Type
    Other
    Date Received
    August 7, 2002
    Date of Event
    May 9, 2002
    Report Date
    August 7, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUYACRO MED VIA A REPORT FROM DR. THAT TWO LUMBAR I/F CAGES WERE REMOVED AND ANALYZED DUE TO A POSSIBLE PSEUDOARTHROSIS. ACCORDING TO THE COMPLAINANT, THE PT UNDERWENT A SINGLE LEVEL ALIF PROCEDURE WITH POSTERIOR INSTRUMENTATION. THE IMPLANT DATE IS UNK. IN 2002, THE PT UNDERWENT A PLIF REVISION FOR PAIN AND A POSSIBLE PSEUDOARTHROSIS. THE TWO REMOVED CAGES WERE NOT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR I/F CAGE SYSTEM LUMBAR CAGE MCV DEPUY ACROMED, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other