BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD CAGE, CURVED 9MM PARALLEL

    MDR report key: 1925527 · Received November 8, 2010

    Report

    Report Number
    1526439-2010-00159
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 11, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K031635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAGE WAS IMPLANTED AND THE BROKEN FRAGMENTS WERE DISCARDED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE MOST LIKELY CAUSE OF THE EVENT IS ATYPICAL FORCE PLACED ON THE CAGE DURING INSERTION. THIS TYPE OF EVENT IS NOT UNANTICIPATED AND THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE WARNS AGAINST THE USE OF ATYPICAL FORCE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE CAGE FRACTURED DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED AND DISCARDED AND THE REMAINING CAGE WAS IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. AS A COMPROMISED DEVICE WAS IMPLANTED, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD CAGE, CURVED 9MM PARALLEL VERTEBRAL BODY REPLACEMENT DEVICE MAX DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR