BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOMA SCREW 5MM, 32CM

    MDR report key: 884619 · Received July 17, 2007

    Report

    Report Number
    2430952-2007-00024
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Report Date
    July 17, 2007
    Manufacturer
    TROKAMED GMBH
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE CORKSCREW SECTION OF THE INSTRUMENT BROKE OFF IN THE FIBROID TISSUE OF THE UTERUS. THE BROKEN PORTION OF THE INSTRUMENT HAS TO BE RETRIEVED LAPAROSCOPICALLY. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOMA SCREW 5MM, 32CM SURGICAL INSTRUMENT MDM TROKAMED GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *