BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSBAR DRIVER

    MDR report key: 3030479 · Received March 27, 2013

    Report

    Report Number
    2032593-2013-00019
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 27, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCT WAS ALSO INVOLVED IN THIS SURGERY: PRODUCT ID (B)(4) (CONTOURED CROSSBAR SMALL 5.5 ROD). TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD INSERTED THE DRIVER INTO A SMALL CROSS BAR TO UNSCREW AND LOOSEN IT IN ORDER TO FIT IT INTO THE PATIENT WHEN THE DRIVER WOULD NOT LET GO OF THE CROSS BAR. IT WOULD SPIN IN EITHER DIRECTION BUT COULD NOT BE REMOVED FROM THE HOLE. THE CROSS BAR DRIVER BECAME STUCK TO THE CONTOURED CROSS BAR. THERE WAS NO SPARE IMPLANT/INSTRUMENT IN THE CASE. THE SURGEON DECIDED IT WAS ACCEPTABLE TO NOT USE A CROSS BAR IN THIS PARTICULAR CASE; IT WAS OPTIONAL. SURGERY TIME WAS NOT EXTENDED - MORE THAN 10 MINUTES DUE TO THE ALLEGED INCIDENT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE ALLEGED INCIDENT. THE INCIDENT WAS PROBABLY OVER IN UNDER TWO MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125467 CROSSBAR DRIVER MALIBU NKB SEASPINE, INC. K04093C

    Patients

    Seq Age Sex Outcome Treatment
    1