BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1587990 · Received January 15, 2010

    Report

    Report Number
    1030489-2010-00062
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    FZS
    PMA / PMN Number
    CUSTOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CURETTE WAS NOT RETURNED FOR EVALUATION. WITH THE AVAILABLE INFORMATION A CAUSE OR CONTRIBUTING FACTOR CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CUSTOM CURETTE BROKE OFF DURING SURGERY. THE TIP BROKE OFF IN THE PATIENT. ALL THE PIECES WERE FOUND AND REMOVED FROM THE PATIENT AND THE STERILE FIELD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT CURETTE FZS MEDTRONIC SOFAMOR DANEK USA, INC. NA H09L017

    Patients

    Seq Age Sex Outcome Treatment
    1