BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELITE EXPANDABLE INTERBODY FUSION DEVICE

    MDR report key: 10853163 · Received November 17, 2020

    Report

    Report Number
    2135156-2020-00004
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    October 19, 2020
    Report Date
    November 17, 2020
    Manufacturer
    SPINEOLOGY INC
    Product Code
    MAX
    PMA / PMN Number
    K162879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE SURGEON: THE PATIENT UNDERWENT A 5 LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. 4 LEVELS WERE COMPLETED AS INTENDED AND WITHOUT PATIENT CONSEQUENCE, BUT THE PATIENT LOST A LOT OF BLOOD. ON THE 5TH LEVEL, A VERY COLLAPSED DISC SPACE, A CHANGE IN FEEDBACK WAS NOTED DURING IMPLANT INSERTION BUT PLACEMENT AND EXPANSION CONTINUED. THE IMPLANT WAS RELEASED FROM THE INSERTER / FORK ASSEMBLY BUT THE IMPLANT POSITIONING WAS NOT IDEAL. THE IMPLANT WAS ATTEMPTED TO BE REENGAGED WITH THE INSERTER / FORK ASSEMBLY BUT A SECURE CONNECTION COULD NOT BE ACHIEVED. A TAMP WAS THEN USED TO ADJUST THE POSITION BUT THE IDEAL LOCATION COULD NOT BE ACHIEVED. A DRIVER WAS THEN USED TO RETURN THE IMPLANT TO ITS STARTING HEIGHT AND FORCEPS WERE USED TO ADJUST THE IMPLANT POSITION. DURING THIS MANEUVER THE IMPLANT DISASSEMBLED IN SITU. THE PROXIMAL WEDGE AND EXPANSION BOLT WERE REMOVED BUT THE DISTAL WEDGE AND TWO ENDPLATE COMPONENTS COULD NOT BE EASILY REMOVED. THE PATIENT CONTINUED TO LOSE A SIGNIFICANT AMOUNT OF BLOOD AND THE DECISION WAS MADE TO LEAVE THE REMAINING IMPLANT COMPONENTS AS POSITIONED. THE PEDICLE SCREWS WERE BEING PLACED AS INTENDED WITH THE INTENT TO FUSE THE ENTIRE SEGMENT BUT THE PATIENT'S CONDITION DETERIORATED AND THE OR TEAM DID A QUICK-CLOSE AND STABILIZED THE PATIENT. THE PATIENT WAS TRANSFERRED TO ICU BUT PASSED AWAY DUE TO CATASTROPHIC BLOOD LOSS. A BLOOD TEST ORDERED DURING SURGERY INDICATED THAT THE PATIENT HAD DISSEMINATED INTRAVASCULAR COAGULATION (DIC), WHICH WAS PREVIOUSLY UNDIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318167 ELITE EXPANDABLE INTERBODY FUSION DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX SPINEOLOGY INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death