BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SINGLE INNIE SET SCREW

    MDR report key: 2808983 · Received October 30, 2012

    Report

    Report Number
    1526439-2012-00240
    Event Type
    Injury
    Date Received
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    KWP
    PMA / PMN Number
    K033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER OR SAMPLE WAS AVAILABLE. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. 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. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    CONTACT REPORTS THE DISTAL SET SCREW OF THE CONSTRUCT HAS LOOSENED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SINGLE INNIE SET SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE KWP DEPUY RAYNHAM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention