BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFS SPINAL FIXATION SYSTEM

    MDR report key: 1919305 · Received November 22, 2010

    Report

    Report Number
    3008524126-2010-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ORTHOFIX INC
    Product Code
    MNH
    PMA / PMN Number
    K994217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFO PROVIDED STATES DURING THE INITIAL IMPLANT OF THE SURGERY, THE ROD BROKE. THE DR HAD TO REMOVE THE SET SCREWS AND START AGAIN WITH A NEW PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SFS SPINAL FIXATION SYSTEM 450MM ROD WITH HEX ENDS SFS HOOK SYSTEM MNH ORTHOFIX INC 57-2145 P10

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR