BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD IMPLANT 5DEG, LOR, 28X7

    MDR report key: 2589855 · Received May 29, 2012

    Report

    Report Number
    1526439-2012-00107
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 23, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MQP
    PMA / PMN Number
    K031635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN THE PATIENT, THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. THE LOT NUMBER IS UNKNOWN AT THIS TIME. BREAKAGE OF ANY CARBON FIBER IMPLANTS IS NOT UNANTICIPATED AND THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THESE PRODUCTS ADDRESS THE FACT THAT EXCESSIVE TORQUE APPLIED TO THE LONG-HANDLE INSERTION TOOLS ATTACHED TO THE INSERTION HOLES OR DIRECT APPLICATION OF LOADS CAN SPLIT OR FRACTURE THE IMPLANTS. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    CONTACT REPORTED LEOPARD CAGE BROKE UPON IMPACTION INTO THE DISC SPACE. THE MAJORITY OF THE CAGE REMAINS IN THE PATIENT. THE BROKEN PIECES WERE REMOVED AND THROWN AWAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD IMPLANT 5DEG, LOR, 28X7 SPINAL VERTEBRAL BODY FIXATION DEVICE MQP DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1