BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 828858 · Received February 21, 2007

    Report

    Report Number
    2242816-2007-00008
    Event Type
    Malfunction
    Date Received
    February 21, 2007
    Date of Event
    January 26, 2007
    Report Date
    February 20, 2007
    Manufacturer
    EBI
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TULIP HEAD CRACKED, WHICH RESULTED IN DOCTOR HAVING TO REMOVE THE SCREW, AND SET SCREW RODS. THE DR HAD TO REIMPLANT ALL OF THE IMPLANTS. DELAYED THE CASE 1/2 HR. PT OUTCOME: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM NKB NKB EBI * 096811

    Patients

    Seq Age Sex Outcome Treatment
    1 *