BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSH BUTTON CAP LOADER

    MDR report key: 3243143 · Received July 18, 2013

    Report

    Report Number
    2032593-2013-00049
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K083089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY FOR A FRACTURE, "THE HEXAGONAL PART OF THE NEWPORT PUSH BUTTON CAP LOADER DID NOT TURN AND THE CAPS FELL DOWN." THE DEVICE WAS IN CONTACT WITH THE PT. THERE WAS NO PT INJURY. THE SURGERY WAS COMPLETED WITH THE USE OF A DIFFERENT DEVICE. THE EVENT LED TO INCREASE THE SURGERY TIME FOR 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335360 PUSH BUTTON CAP LOADER NEWPORT NKB SEASPINE, INC. AR52949B

    Patients

    Seq Age Sex Outcome Treatment
    1