BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 3786337 · Received April 17, 2014

    Report

    Report Number
    3005039508-2014-00001
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    February 4, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS SHOW THAT PARTS IN THE FIELD MET RELEASE REQUIREMENTS PRIOR TO DISTRIBUTION. DEVICE FROM NON-RELEASED INVENTORY EVALUATED AND MET SPECIFICATION.

    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 PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236390 MINI MAXLOCK EXTREME ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ORTHOHELIX SURGICAL DESIGNS INC MXM-056T 2615012

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other