BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLAR SPACER SYSTEM

    MDR report key: 2208747 · Received August 4, 2011

    Report

    Report Number
    3008524126-2011-00023
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    March 15, 2010
    Report Date
    July 29, 2011
    Manufacturer
    ORTHOFIX INC
    Product Code
    MAX
    PMA / PMN Number
    K081177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IN THE PT.

    Description of Event or Problem · 1

    DURING CASE ON (B)(6) 2010, A PEEK INTERBODY CAGE WAS INSERTED INTO THE L-5 AREA. THE IMPLANT WAS LOST AND NOT RETRIEVABLE. THE SURGEON ADVISED THE PT THAT HE TRIED TO RETRIEVE THE PART BUT COULD NOT. THE PEEK IS NOW ATTACHED TO AND PUSHING ON THE LEFT COMMON ILIAC VEIN. A PERMANENT STENT HAS BEEN IMPLANTED INTO THE LEFT COMMON ILIAC VEIN TO KEEP IT OPEN SO THAT THE BLOOD FLOW FROM THE HEART CAN WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLAR SPACER SYSTEM 9MMX23MM 8DEG. LORDOTIC SPACER ASSEMBLY MAX ORTHOFIX INC 45-6308 E04

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability