BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW EMERGENCY SET

    MDR report key: 2091117 · Received May 10, 2011

    Report

    Report Number
    2091117
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 4, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN OPEN REDUCTION AND INTERNAL FIXATION OF FRACTURED MANDIBLE/FX LEFT ANGLE. PATIENT'S #17 WISDOM TOOTH WAS IMPACTED HORIZONTALLY WITH EVIDENCE OF INFECTION. SURGICAL DEBRIDEMENT, PLACEMENT OF HARDWARE AND SURGICAL REMOVAL OF TOOTH #17 WAS DONE ON PATIENT. WHILE USING A SCREWDRIVER FROM THE SYNTHES FACIAL FX SET, THE TEETH OF THE SCREWDRIVER BROKE OFF. PIECES WERE EXTRACTED AND CASE WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW EMERGENCY SET MANDIBULAR FIXATION SYNTHES FACIAL FX SET JEY SYNTHES USA 401.558E, 936E, 934E, 510E, 057 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR