BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 400965 · Received June 20, 2002

    Report

    Report Number
    1526439-2002-00045
    Event Type
    Other
    Date Received
    June 20, 2002
    Date of Event
    June 6, 2002
    Report Date
    June 20, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT THE BASE OF THE CAGE BROKE OFF FROM THE STRUTS OF THE CAGE. ACCORDING TO THE COMPLAINANT, THE CAGE WAS IMPACTED WITH BONE GRAFT AND THREADED TO THE INSERTER. THE BASE OF THE CAGE BROKE OFF DURING INSERTION AND THE REMAINING PIECE WAS STILL ATTACHED TO THE INSERTER. THE SURGEON LEFT THE CAGE IMPLANTED. ONLY THE BASE OF THE CAGE WAS RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. A DIMENSIONAL ANALYSIS WAS NOT POSSIBLE AS ONLY THE BASE OF THE CAGE WAS RETURNED FOR EVALUATION. THE COMPLAINANT DID NOT REPORT THE LOT NUMBER.

    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 40 YR Other