BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXLOCK

    MDR report key: 3676549 · Received March 6, 2014

    Report

    Report Number
    3676549
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING SCREW INTO PLATE ON A METAPHALANGEAL JOINT FUSION, THE SCREWDRIVER END BROKE OFF FLUSH INSIDE THE SCREW AND COULD NOT BE REMOVED FROM THE SCREW. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134960 MAXLOCK INSTRUMENT, SURGICAL, ORTHOPEDIC LXH ORTHOHELIX SURGICAL DESIGNS, INC. * 2615012

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR