BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCELOT STACK I/F CAGE M 7X11 TOP

    MDR report key: 4240671 · Received November 10, 2014

    Report

    Report Number
    1526439-2014-12067
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 13, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK001340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE HAS BEEN EVALUATED BY THE COMPLAINTS HANDLING UNIT. THE RETURNED CAGE FEATURES A HAIRLINE FRACTURE AT THE BRIDGE ACROSS THE CENTER OF A CAGE, WHICH IS ITS THINNEST POINT. NO FRAGMENTS OF THE CAGE HAVE SPLINTERED OFF FROM THE MAIN BODY. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED ON THE SPECIFIC CODE AS THE FRACTURE PROFILE CHANGES IN ACCORDANCE TO ITS DIMENSIONS. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLES AND INFORMATION PROVIDED. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INSPECTION OF EXPRESSCARE KIT BY DEPUY SYNTHES SPINE FOUND FOUR OCELOT STACKABLE CAGES WERE BROKEN. IT IS UNKNOWN WHERE/WHEN CAGE BREAKAGE OCCURRED. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE FOUR CAGES: 1526439-2041-12067; 1526439-2014-12068; 1526439-2014-12069; 1526439-2014-12070.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723408 OCELOT STACK I/F CAGE M 7X11 TOP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE DP254360

    Patients

    Seq Age Sex Outcome Treatment
    1