BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE QUATTRO SPIKE, LONG

    MDR report key: 10648036 · Received October 8, 2020

    Report

    Report Number
    10648036
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 5, 2020
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOW PROFILE QUATTRO SPIKE - LONG - NO LONG OBTURATOR, ONLY MEDIUM LENGTH IN SET - TIPS BENT WHILE USING IN PATIENT, NO PARTS BROKEN, ONLY BENT, PART TAKEN OUT OF SERVICE. NO HARM TO THE PATIENT. OR STAFF WAS TOLD BY THE GLOBUS REP. THAT THIS HAPPENED BECAUSE THE ROD USED TO PROTECT THIS INSTRUMENT WASN'T INSERTED ALL THE WAY DOWN, AND ONCE THE MALLET WAS USED TO INSERT IT ¿ IT BENT THE END OF THE INSTRUMENT. THE STAFF WAS TOLD TO TAKE AN X-RAY TO MAKE SURE THERE WERE NO PARTICLES, EVEN THOUGH GLOBUS REP. STATED IT ONLY BENT DOWN. LOW PROFILE QUATTRO SPIKE LONG GLOBUS MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114491 LOW PROFILE QUATTRO SPIKE, LONG ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO GLOBUS MEDICAL, INC. 6143.2519

    Patients

    Seq Age Sex Outcome Treatment
    1 19710 DA