BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 448862 · Received March 19, 2003

    Report

    Report Number
    1526439-2003-00020
    Event Type
    Other
    Date Received
    March 19, 2003
    Date of Event
    December 3, 2002
    Report Date
    March 19, 2003
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MAX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LUMBAR I/F CAGE BROKE TWO YEARS POST-OPERATIVELY. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED A LATE INFECTION AND A NON-UNION WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE CAGE WAS EXPLANTED IN 2002. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICES HAS NOT BEEN RETURNED FOR EVALUATION. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR I/F CAGE SYSTEM LUMBER CAGE MAX DEPUY ACROMED, INC. NA K3055

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other