BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 919108 · Received September 24, 2007

    Report

    Report Number
    2242816-2007-00038
    Event Type
    Injury
    Date Received
    September 24, 2007
    Date of Event
    August 14, 2007
    Report Date
    August 31, 2007
    Manufacturer
    EBI, L.P.
    Product Code
    NKB
    PMA / PMN Number
    K061563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ARRAY PEDICLE SCREWS IMPLANTED IN 2007, IN THE SACRAL LEVEL WERE OBSERVED TO BE BROKEN SEVEN MONTHS LATER VIA X-RAY. PATIENT OUTCOME: REPORTED ON AUGUST 16, 2007, PATIENT HAS INCREASING LOWER BACK PAIN AND RIGHT LEG PAIN IN THE LAST 6 WEEKS. RE-OPERATION PERFORMED THIRTEEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM NKB EBI, L.P. 359642

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention