BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONIC CTRL SERRATED AGG KNIFE

    MDR report key: 5467804 · Received February 29, 2016

    Report

    Report Number
    0001811755-2016-00249
    Event Type
    Injury
    Date Received
    February 29, 2016
    Date of Event
    January 27, 2016
    Report Date
    February 2, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LFL
    PMA / PMN Number
    K020220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW UP WITH THE CUSTOMER, IT WAS IDENTIFIED THAT DURING USE THE DEVICE WAS BEING USED OUTSIDE OF THE INTENDED DUTY CYCLE DURING AN EXTENSIVE PROCEDURE. THE CONCOMITANT PRODUCTS WERE RETURNED FOR EVALUATION AND NO RELATED FAILURES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGICAL PROCEDURE AT THE USER FACILITY, THE TIP OF THE DEVICE BECAME HOT. DURING THIS TIME THE DEVICE BURNED A HOLE IN THE DURA MATER OF THE SPINAL CORD. THE SURGEON REPAIRED THIS WITH SUTURING AND COMPLETED THE PROCEDURE SUCCESSFULLY; NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124901 SONIC CTRL SERRATED AGG KNIFE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention