BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4861909 · Received June 1, 2015

    Report

    Report Number
    4861909
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 14, 2015
    Manufacturer
    MEDARTIS, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDARTIS CANNULATED SCREW BROKE IN PATIENT. OBTAINED UNIVERSAL BROKEN SCREW REMOVAL KIT AND A PORTION OF THE SCREW WAS SUCCESSFULLY REMOVED. THE EXTRACTOR USED TO REMOVE REMAINING PIECE OF SCREW ALSO BROKE. ANOTHER EXTRACTOR WAS OBTAINED AND THE REMAINING FRAGMENT OF THE SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353937 * SCREW HWC MEDARTIS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR