BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SPINAL FIXATION SYSTEM

    MDR report key: 2935702 · Received January 3, 2013

    Report

    Report Number
    3008524126-2012-00031
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ORTHOFIX INC.
    Product Code
    MNI
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED (15) 52-6800 INTERNAL SET SCREWS MALFUNCTIONED DURING CASE. THE CRACKED INTERNAL SET SCREWS AND 2 OF THE PARALLEL ROD CONNECTORS WERE REPLACED. THERE WERE NO CONTRIBUTING FACTORS AND THE PATIENT WAS SENT TO POST-OPERATIVE RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3907 FIREBIRD SPINAL FIXATION SYSTEM 5.5MM X 5.5MM PARALLEL ROD CONNECTOR MNI ORTHOFIX INC. 52-6800 (2) B03, F01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR