BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 4536715 · Received February 17, 2015

    Report

    Report Number
    3006639916-2015-00019
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 20, 2015
    Report Date
    February 17, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCESS OF TIGHTENING OF THE SCREW IN THE PT, ONCE THE SCREWDRIVER WAS REMOVED, THE SURGEON REALIZED THAT THE RETENTION SYSTEM OF THE SCREWDRIVER WAS BROKEN. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114041 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1316455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other