BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD IMPLANT 5? LORDOTIC, 12MM

    MDR report key: 2822602 · Received November 7, 2012

    Report

    Report Number
    1526439-2012-00254
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE, AS THE DEVICE IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE DEVICE LOT CODE IS UNKNOWN. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE LEOPARD CAGE BROKE INTO PIECES DURING INSERTION INTO THE INTERVERTEBRAL SPACE. REPORTS THE SURGEON HAMMERED THE CAGE WHICH IT BROKE. THERE WAS A DELAY OF ABOUT 10 MINUTES. IT IS NOT KNOWN IF ALL OF THE BROKEN PIECES OF THE CAGE WERE REMOVED FROM THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD IMPLANT 5? LORDOTIC, 12MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY RAYNHAM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1