BEUDAMED
    FDA Adverse Event Other Summary report: N

    KYPHX LATITUDE II CURETTE

    MDR report key: 1290905 · Received November 20, 2008

    Report

    Report Number
    2953769-2008-00057
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    FZS
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - FOLLOW UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    DURING A KYPHOPLASTY PROCEDURE, THE SURGEON USED A CURETTE. THE BREAK-AWAY SAFETY MECHANISM OF THE CURETTE WAS ACTIVATED AND THE SURGEON NOTED RESISTANCE UPON REMOVAL OF THE CURETTE. A SMALL PORTION OF THE CURETTE REMAINED IN THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX LATITUDE II CURETTE ORTHOPEDIC CURETTE FZS MEDTRONIC SPINE LLC. NA J8030514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK