BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGUAR LUMBAR CAGE

    MDR report key: 1360758 · Received March 2, 2009

    Report

    Report Number
    1526439-2009-00036
    Event Type
    Malfunction
    Date Received
    March 2, 2009
    Date of Event
    February 3, 2009
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    P960025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND SOMETHING OTHER THAN WHAT IS STATED BELOW IS FOUND, A FOLLOW UP REPORT SHALL BE FILED. THE MOST LIKELY CAUSE OF THE EVENT IS EXCESSIVE FORCE PLACED ON THE CAGE DURING INSERTION. THIS TYPE OF EVENT IS NOT UNANTICIPATED AS THE INSTRUCTIONS FOR USE CONTAINED IN THE PACKAGING OF THIS PRODUCT STATES THAT EXCESSIVE TORQUE APPLIED TO THE LONG-HANDLE INSERTION TOOLS ATTACHED TO THE INSERTION HOLES OR DIRECT APPLICATION OF LOADS OF THE THREADED OR SMALL AREA OF THE CAGE COMPONENT CAN SPLIT OR FRACTURE THE CAGE IMPLANTS.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT A VBR CAGE BROKE DURING INSERTION. PIECES WERE REMOVED AND ANOTHER CAGE WAS PLACED. THE CONTACT REPORTED THAT THEY COULD NOT BE SURE THAT ALL THE FRAGMENTS WERE RETRIEVED. THERE WAS NO ADVERSE PT CONSEQUENCES AS A RESULT OF THIS SITUATION. AS AN UNINTENDED PORTION OF THE DEVICE MAY HAVE BEEN LEFT IN THE BODY, AN MDR WAS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGUAR LUMBAR CAGE VBR MAX DEPUY SPINE, INC. NA AJJC2B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK