BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SI POLYAXIAL SCREW

    MDR report key: 2880162 · Received December 19, 2012

    Report

    Report Number
    1526439-2012-00311
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 27, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NKB
    PMA / PMN Number
    K033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE LOT CODE IS UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. EXAMINATION OF MRI IMAGES PROVIDED WERE INCONCLUSIVE. 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 RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT L4/L5 INSTRUMENTATION WAS PERFORMED WITH THE EXPEDIUM SYSTEM FOR SPINAL CANAL STENOSIS AND SPONDYLOLISTHESIS. WHEN EXAMINING IMAGES FOR POSTOPERATIVE DIAGNOSIS, THE SURGEON FOUND SCREW LOOSENING OF L4. THE PATIENT BEING MONITORED BY THE SURGEON AND IS WEARING A CORSET. REVISION SURGERY IS NOT PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SI POLYAXIAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention