BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEOPARD IMPLANT 5DEG, LOR, 28X7

    MDR report key: 2678689 · Received August 2, 2012

    Report

    Report Number
    1526439-2012-00154
    Event Type
    Injury
    Date Received
    August 2, 2012
    Date of Event
    July 10, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MQP
    PMA / PMN Number
    K031635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED. THE MOST LIKELY CAUSE OF THE CAGE BREAKAGE 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    CONTACT REPORTED A LEOPARD CAGE BROKE UPON INSERTION DURING A SPINE PROCEDURE. IT WAS REPORTED THE PATIENT HAD A VERY COLLAPSED DISC SPACE. SURGEON FEELS THE BREAKAGE WAS DUE TO THE TIGHT DISC SPACE. BROKEN CAGE REMAINS IN THE PATIENT AS SURGEON FEELS IT IS SECURE. 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 REPLACEMENT DEVICE MQP DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention