BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT LATERAL INSERTER DRAW ROD 8MM LORDOTIC

    MDR report key: 3960768 · Received June 10, 2014

    Report

    Report Number
    2032593-2014-00027
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 15, 2014
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSERTER SHAFT BROKE UPON INSERTING THE VU A POD-L TRIAL INTO THE PATIENT. ON (B)(6) 2014, ADDITIONAL INFORMATION WAS RECEIVED. THE SURGERY WAS LATERAL IMPLANT SURGERY L1-L2. THE INSERTER (31-40-0282) TIP BROKE OFF IN THE VU A POD-L TRIAL. THE SURGERY TIME WAS INCREASED 7 TO 8 MINUTES. THE SURGEON USED TWO KOCHER INSTRUMENTS TO REMOVE THE TRIAL. THE CUSTOMER CONFIRMED THERE WAS NOTHING WRONG WITH THE TRIAL; IT WAS THE INSERTER THAT BROKE. THE TRIAL WAS RETURNED AND WAS UNUSABLE BECAUSE IT HAD THE TIP OF THE INSERTER IN IT. THE SURGEON USED A TRIAL IN THE NEXT SIZE UP TO DETERMINE THE CORRECT IMPLANT SIZE TO USE TO COMPLETE THE SURGERY. THERE WERE NO PARTS OF THE DEVICE RETAINED INSIDE THE PATIENT. THERE WAS NO ADVERSE CONSEQUENCE OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337039 STRAIGHT LATERAL INSERTER DRAW ROD 8MM LORDOTIC SPINAL INSTRUMENTS - FIXED NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1