BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 921804 · Received October 1, 2007

    Report

    Report Number
    2242816-2007-00043
    Event Type
    Injury
    Date Received
    October 1, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 13, 2007
    Manufacturer
    EBI
    Product Code
    NKB
    PMA / PMN Number
    K061563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LOOSENING OF SET SCREWS AND LOST OF CONSTRUCT DETECTED 6 MONTHS POST-OP OF SPINAL SURGERY. REVISION SURGERY PERFORMED. PATIENT STATUS IS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM NKB EBI 399700

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization