BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZATION SCREW, 3MM DIA X 16MM LGTH

    MDR report key: 1081567 · Received July 25, 2008

    Report

    Report Number
    9615741-2008-00014
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 8, 2008
    Report Date
    July 25, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT AS THE DEVICE WAS BEING PLACED, THE DISTAL THREADS BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZATION SCREW, 3MM DIA X 16MM LGTH LOWER EXTREMITY FIXATION SCREW HWC NEWDEAL S.A. 111316

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR