BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER 4MM

    MDR report key: 3960592 · Received June 20, 2014

    Report

    Report Number
    2032593-2014-00030
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE "HEX DRIVER 91-8432 FULLY SEATED LINE WAS NOT IN THE CORRECT LOCATION." THIS WAS NOTICED IN THE CUSTOMER'S OFFICE AND NOT USED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363563 HEX DRIVER 4MM NEWPORT NKB SEASPINE, INC. M010656C/AU3365402A

    Patients

    Seq Age Sex Outcome Treatment
    1