BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE WAVE

    MDR report key: 6707721 · Received July 12, 2017

    Report

    Report Number
    6707721
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 13, 2017
    Manufacturer
    3 ENTERPRISE DR #210
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SCREW WAS INSERTED WHILE ATTACHED TO SCREW INSERTER THAT CONSISTS OF TWO PARTS. WHEN IT WAS DISCONNECTED FROM THE EXTENSION, PART OF THE EXTENSION AT THE DISTAL END BROKE OFF. THIS HAPPENED TWO TIMES. THE ....

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489067 SPINE WAVE SNIPER PEDICLE SCREW SYSTEM MNI 3 ENTERPRISE DR #210

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR