BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SQUID INSERTER

    MDR report key: 3979003 · Received July 18, 2014

    Report

    Report Number
    3979003
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE BROKE WHEN BEING USED TO INSERT A SPINAL IMPLANT. IT WAS DETERMINED THAT IT WAS IN THE PATIENT'S BEST INTEREST TO LEAVE THE RETAINED FRAGMENT IN PLACE. THIS DEVICE IS USED TO PLACE FIXATION HARDWARE IN THE SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423539 SQUID INSERTER APPLIANCE, FIXATION KWQ ALPHATEC SPINE INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR