BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE SYSTEM STERILE IMPLANT KIT 1.9MM X 15MM

    MDR report key: 4240031 · Received November 3, 2014

    Report

    Report Number
    3005039508-2014-00012
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    May 10, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    JDR
    PMA / PMN Number
    K130832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    STAPLE BROKE WHILE THE PT WAS REHABBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703899 STAPLE SYSTEM STERILE IMPLANT KIT 1.9MM X 15MM NONE JDR ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1