BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERPLATE L-TI LUMBAR PLATE/IFD/VBR

    MDR report key: 2306135 · Received October 17, 2011

    Report

    Report Number
    3003597504-2011-00002
    Event Type
    Death
    Date Received
    October 17, 2011
    Report Date
    October 14, 2011
    Manufacturer
    RSB SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K071922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS BUT DO NOT APPEAR IMPLICATED IN THE ADVERSE EVENT.

    Description of Event or Problem · 1

    A THREE LEVEL LUMBAR INTERBODY FUSION WAS PERFORMED ON (B)(6) 2011. THE PT SUBSEQUENTLY DIED DUE TO A PULMONARY EMBOLISM. PULMONARY EMBOLISM IS A KNOWN COMPLICATION OF ANTERIOR LUMBAR SPINE SURGERY. DEATH RESULTING FROM PULMONARY EMBOLISM HAD A REPORTED FREQUENCY OF 2% IN ONE STUDY. THE LITERATURE DOES NOT IMPLICATE IMPLANT DESIGN AS A CAUSATIVE FACTOR FOR EMBOLISM AND THAT APPEARS TO BE THE CASE IN THE CURRENT SITUATION. AN MDR IS BEING FILED DUE TO THE SERIOUS NATURE OF THE ADVERSE EVENT. ADDITIONAL INFO WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPLATE L-TI LUMBAR PLATE/IFD/VBR KWQ, MAX, MQP KWQ RSB SPINE RSB121439, 081439

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death