BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW 6.0MM X 30 MM

    MDR report key: 2437913 · Received January 16, 2012

    Report

    Report Number
    2032593-2011-00024
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 6, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREADS ON A 6.0 MM BONE SCREW STRIPPED OFF AS THE SURGEON WAS ADVANCING THE SCREW THROUGH THER PLATE. THE SURGEON PREPARED THE SCREW HOLE USING THE AWL AND DRILL BEFORE IMPLANTING THE SCREW. THE REPORTER STATED "HALFWAY DOWN THE SCREW SHAFT THE OUTER PART OF THE SCREW THREADS BEGAN TO PEEL OFF THE SCREW." THE FRAGMENTS WERE STILL ATTACHED TO THE SCREW AS THE SURGEON REMOVED THE SCREW." NO ADVERSE EVENT TO REPORT OR FRAGMENTS LET IN THE PATIENT. AN APPROXIMATE DELAY IN SURGERY OF TEN MINUTES WAS REPORTED. THE SURGEON HAD NO DIFFICULTY LOCKING THE SYSTEM COMPLETELY AT THE END OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW 6.0MM X 30 MM ZUMA ODP SEASPINE, INC. P809105A

    Patients

    Seq Age Sex Outcome Treatment
    1