BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBR WDG I/F CGE(9X11)X9X23

    MDR report key: 2886327 · Received December 26, 2012

    Report

    Report Number
    1526439-2012-83565
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    December 13, 2012
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PP960025/S8
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAGE REMAINS IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DHR FOUND NO DISCREPANCIES. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS "FUNCTIONAL REPRESENTATION FROM R&D, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. CAGE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS A SPINAL CAGE DROPPED ANTERIORLY FROM L5-S DURING SURGERY AND COULD NOT BE REMOVED. THE DEVICE WAS THE FIRST CAGE TO BE INSERTED AND IT DROPPED ANTERIORLY WHEN THE SURGEON TRIED TO INSERT THE NEXT CAGE. THE PROCEDURE WAS COMPLETED WITH THE CAGE LEFT IN THE PATIENT'S BODY. THE SURGICAL PROCEDURE TIME WAS EXTENDED BY 120 MINUTES. ACCORDING TO THE SURGEON, INSERTING TOO MUCH GRAFTED BONE COULD HAVE BEEN A CAUSE OF THE EVENT. HE REPORTS THAT THERE WERE NO QUALITY ISSUES WITH THE CAGE. THE PATIENT'S CONDITION IS BEING MONITORED AND THERE ARE NO PLANS FOR REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBR WDG I/F CGE(9X11)X9X23 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE K5628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention