BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT 90 DEGREE MIS ROD INSERTER

    MDR report key: 3769218 · Received January 10, 2014

    Report

    Report Number
    2032593-2013-00093
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 16, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS CONCERNING THE SAME PATIENT AND SAME SURGERY. THIS REPORT CONCERNS THE NEWPORT 90 DEGREE MIS ROD INSERTER (PRODUCT ID CUST0026). FIRST REPORT FILED UNDER MFG REPORT NUMBER 2032593-2013-00092."TIP OF INSTRUMENT BROKE OFF LEFT IN PATIENT." ADD'L INFO WAS RECEIVED ON (B)(6) 2013 FROM THE CUSTOMER. DURING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY, THE TIP OF THE INSERTER BROKE OFF INTO THE SCREW DURING INSERTION OF THE LOCKING ROD. THE TIP WAS REMOVED WITH SUCTION. SURGERY WAS DELAYED 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20744 NEWPORT 90 DEGREE MIS ROD INSERTER SPINAL INSTRUMENTS - FIXED NKB SEASPINE, INC. W17922

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR