BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROW FUSION

    MDR report key: 3632493 · Received February 6, 2014

    Report

    Report Number
    3009511077-2014-00001
    Event Type
    Injury
    Date Received
    February 6, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    NLT SPINE
    Product Code
    MAX
    PMA / PMN Number
    K130254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IMPLANT FOUND TO BE COMPLETE AND NOT DAMAGED.

    Description of Event or Problem · 1

    TWO WEEKS FOLLOWING A LUMBAR FUSION SURGERY, THE PT FELTED RADIATING PAIN IN THE LEG. ON C.T. IT WAS FOUND THAT THE IMPLANT WAS PARTIALLY MIGRATED. REVISION SURGERY WAS PERFORMED. THE IMPLANT WAS REPLACED WITH ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78826 PROW FUSION PROW FUSION MAX NLT SPINE FU-I2-1310 F00044

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention