BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HARVESTER HANDLE MODULAR

    MDR report key: 3243152 · Received July 18, 2013

    Report

    Report Number
    2032593-2013-00048
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K082310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 THE DEVICE BROKE AT THE THREADS DURING SURGERY WITH NORMAL USAGE. THE TIP WAS RECOVERED AND A ONE MINUTE DELAY IN SURGERY WAS REPORTED. THERE WAS A SQUARE DEVICE AVAILABLE THAT FUNCTIONED PROPERLY. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335385 SMALL HARVESTER HANDLE MODULAR TITANIUM SPACER MAX SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR