BEUDAMED
    FDA Adverse Event Death Summary report: N

    1030489-2016-02888

    MDR report key: 6029198 · Received October 14, 2016

    Report

    Report Number
    1030489-2016-02888
    Event Type
    Death
    Date Received
    October 14, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS OBLIQUE LUMBAR INTERBODY FUSION 4-5 AND 5-1. INTRA-OP, THE PATIENT DECEASED. THE EVENT WAS RELATED TO EXPOSURE OF L5-S1 OBLIQUE/ANTERIOR APPROACH. THE SURGEON COMPROMISED THE ILIAC VEIN DURING EXPOSURE RESULTING IN BLEEDING. SURGEON THEN ATTEMPTED TO REPAIR, TRANSFUSION OF BLOOD AND PLASMA. THE REST OF THE PROCEDURE WENT WELL, WHILE REMOVING RETRACTOR BLADES, MORE BLEEDING OCCURRED THAT THEY WERE NOT ABLE TO CONTROL. NO DEVICE PROBLEM WAS REPORTED. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT BUT DIDN'T CAUSED THE ISSUE. THE ISSUE WAS CAUSED DURING EXPOSURE USING HOSPITAL EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681822 OVD MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death