BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNIPER LOCKING SCREW

    MDR report key: 3221062 · Received July 3, 2013

    Report

    Report Number
    3004638600-2013-00008
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K081228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCKING SCREWS WERE RETURNED FOR EVAL. VISUAL EXAMINATION WAS PERFORMED. ALL DEVICES EXHIBITED SIGNS OF USE AND WEAR ASSOCIATED WITH THE REPORTED EVENT. THE MATING PARTS WERE NOT AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED ISSUES. IN ADDITION, TWO TIGHTENING INSTRUMENTS WERE RETURNED FOR EVAL. THESE DEVICES FUNCTIONED AS INTENDED; NO VISUAL OR FUNCTIONAL ABNORMALITIES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED ISSUES. BASED ON THE RESULTS OUR EVAL, NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING ROUTINE POST-OPERATIVE RADIOGRAPHIC EXAMINATION, THE SURGEON NOTED LOCKING SCREWS WERE NOT ENGAGED WITH THE PEDICLE SCREW CONSTRUCT. THE PT UNDERWENT SURGERY TO REMOVE AND REPLACE THE LOCKING SCREWS. THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305638 SNIPER LOCKING SCREW PEDICLE SCREW SYSTEM MNI SPINE WAVE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention