BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD VBR DEVICE

    MDR report key: 1182696 · Received September 25, 2008

    Report

    Report Number
    1526439-2008-00169
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K031635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE PLACED UPON THE CAGE DURING INSERTION OF FAILURE TO PROPERLY CLEAR THE DISC SPACE PRIOR TO CAGE INSERTION. A FOLLOW UP REPORT WILL BE FILED IF EXAMINATION OF THE RETURNED CAGE REVEALS SOMETHING OTHER THAN THAT WHICH IS STATED ABOVE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT THE POSTERIOR SECTION OF A LEOPARD CAGE BROKE WHILE BEING IMPACTED INTO POSITION DURING SPINAL SURGERY. A PORTION OF THE CAGE COULD NOT BE RETRIEVED AND REMAINS IN THE PATIENT. THE SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES AS A RESULT OF THE DIFFICULTY. AS A SECTION OF THE BROKEN CAGE REMAINS IN THE PATIENT, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD VBR DEVICE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LEOPARD QUICK RELEASE INSERTER