BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLAR SPACER SYSTEM

    MDR report key: 3853534 · Received June 3, 2014

    Report

    Report Number
    3008524126-2014-00013
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ORTHOFIX INC.
    Product Code
    MAX
    PMA / PMN Number
    K081177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED THE SURGEON WENT TO TAP THE IMPLANT INTO PLACE THE IMPLANT DISLODGED FROM THE INSERTER AND HAD TO BE RETRIEVED. UPON INSPECTION THEY NOTICED THAT THE CONNECTION POINT OF THE INSERTER TO THE GRAFT HAD BROKEN AND THE GRAFT WAS FRACTURED RESULTING IN NERVE DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324309 PILLAR SPACER SYSTEM PILLAR TL 8MM X 9MM X 27MM IMPLANT MAX ORTHOFIX INC. 45-7208

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other