BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 837235 · Received February 20, 2007

    Report

    Report Number
    2242816-2007-00007
    Event Type
    Malfunction
    Date Received
    February 20, 2007
    Date of Event
    January 16, 2007
    Report Date
    February 15, 2007
    Manufacturer
    EBI
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF THE LEFT SIDE ARRAY FUSION CONSTRUCT L3-S1 ON INSPECTION OF THE S1 SCREW. THE HEAD HAD BROKEN INSITU FROM THE SHAFT, 3 THREADS DOWN. PATIENT OUTCOME: NO PATIENT COMPLICATIONS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM NKB NKB EBI * 169904

    Patients

    Seq Age Sex Outcome Treatment
    1 *