BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONIC CTRL SERRATED AGG KNIFE

    MDR report key: 3440185 · Received October 31, 2013

    Report

    Report Number
    0001811755-2013-02709
    Event Type
    Injury
    Date Received
    October 31, 2013
    Date of Event
    October 4, 2013
    Report Date
    November 30, 2020
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONIC CTRL SERRATED AGG KNIFE WAS BEING USED IN A PROCEDURE WHEN THE TIP CAUGHT THE DURA RESULTING IT NEEDING TO BE STITCHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO OTHER PATIENT OR USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559269 SONIC CTRL SERRATED AGG KNIFE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention