BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORZA

    MDR report key: 3779479 · Received April 24, 2014

    Report

    Report Number
    3008524126-2014-00010
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ORTHOFIX INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFO PROVIDED, THE SPACER DISLODGED FROM THE 80-5200 INSERTER AND WENT FORWARD INTO THE ABDOMINAL CAVITY. THE SPACER WAS RETRIEVED AND THE PT DID NOT HAVE ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248909 FORZA 9MM STRAIGHT IMPLANT CATHETER MAX ORTHOFIX INC. 80-5200 42009-PF26

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention