BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER EXTENSION TOWER SPINE WAVE

    MDR report key: 4922021 · Received July 10, 2015

    Report

    Report Number
    MW5044266
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SPINE WAVE
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SPINE WAVE SNIPER EXTENSION TOWER BROKE OFF IN PT DURING FINAL TIGHTENING. BROKEN TABS WERE FOUND AND RECOVERED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450103 SNIPER EXTENSION TOWER SPINE WAVE SNIPER EXTENSION TOWER SPINE WAVE MNH SPINE WAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR