BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXLOCK

    MDR report key: 851226 · Received May 15, 2007

    Report

    Report Number
    3005039508-2007-00008
    Event Type
    Malfunction
    Date Received
    May 15, 2007
    Date of Event
    April 19, 2007
    Report Date
    April 19, 2007
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HTW
    PMA / PMN Number
    K060428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST OCCURRENCE IN 794 SURGERIES WITH THIS PRODUCT SYSTEM.

    Description of Event or Problem · 1

    DURING A LAPIDUS SURGERY, A 2.4MM DRILL BIT BROKE. THE BROKEN PORTION OF THE DRILL BIT WAS NOT REMOVED. THE PT WAS REPORTED TO BE FINE POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXLOCK FRACTURE REPAIR PLATE AND SCREW SYSTEM HTW ORTHOHELIX SURGICAL DESIGNS, INC. MXS-072-24 NG362

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention