BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTRUX MINI PEEK VBR SYSTEM

    MDR report key: 6133865 · Received November 29, 2016

    Report

    Report Number
    2183449-2016-00023
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    August 11, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ORTHOFIX INC
    Product Code
    MQP
    PMA / PMN Number
    K051246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED STATES THAT DURING THE INITIAL SURGERY, AT THE TIME OF IMPACTION, TWO OF THE CAGES CRACKED. SINCE THE SURGERY, THE PATIENT HAS MADE GOOD PROGRESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784767 CONSTRUX MINI PEEK VBR SYSTEM PARALLEL LATERAL SPACER 10MM MQP ORTHOFIX INC 45-3210 D700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other