BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW DRIVER

    MDR report key: 3633950 · Received January 18, 2014

    Report

    Report Number
    2032593-2013-00089
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Date of Event
    November 21, 2013
    Report Date
    November 26, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    HXX
    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 RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS CONCERNING THE SAME PT AND SAME SURGERY. THIS REPORT CONCERNS PRODUCT 91-2110 (POLYAXIAL SCREW DRIVER). IT WAS REPORTED "DURING SPINE SURGERY, THE DEVICE WOULD RATCHET". ADDITIONAL INFO WAS OBTAINED ON (B)(6) 2013: THE DEVICE WOULD NOT RATCHET DURING SCREW IMPLANTATION. A SPARE WAS AVAILABLE THAT FUNCTIONED PROPERLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT RELATED TO THIS. SURGERY WAS DELAYED LESS THAN A MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46296 POLYAXIAL SCREW DRIVER MALIBU HXX SEASPINE, INC. AL546768F

    Patients

    Seq Age Sex Outcome Treatment
    1