BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IEXP TI DOUBLE WIRE COCR

    MDR report key: 2858630 · Received December 5, 2012

    Report

    Report Number
    1526439-2012-83156
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 17, 2012
    Report Date
    December 5, 2012
    Manufacturer
    DEPUY SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK101070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN PATIENT. NO PRODUCT PROBLEM REPORTED. 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 R&D, 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. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    CONTACT REPORTED THE PATIENT EXPIRED TWO WEEKS POST-OPERATIVE. NO PRODUCT PROBLEM REPORTED. HOSPITAL WAS CONTACTED BUT UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION. CAUSE OF DEATH IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IEXP TI DOUBLE WIRE COCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE KWP DEPUY SPINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other