BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 872171 · Received March 12, 2007

    Report

    Report Number
    2242816-2007-00012
    Event Type
    Malfunction
    Date Received
    March 12, 2007
    Date of Event
    May 23, 2006
    Report Date
    March 9, 2007
    Manufacturer
    EBI
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCREW BROKE AT S1 AND TWO THREADS DOWN FROM HEAD. PT OUTCOME: PT HAS NO ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM NKB NKB EBI 94645 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *