BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    MDR report key: 9488220 · Received December 18, 2019

    Report

    Report Number
    1030489-2019-01437
    Event Type
    Death
    Date Received
    December 18, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOMES TO ADVERSE EVENT: OTHER: VENOUS BLEEDING. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART#: 2968055, LOT#: YY04, 510K#: K083026, UDI# (B)(4), QTY# 1; PART#: 2140135, LOT#: 0716750W, 510K#: K152277, UDI# (B)(4), QTY# 1; PART#: 2140001, LOT#: 0533004W, 510K#: K152277, UDI# (B)(4), QTY# 1; PART#: 2140135, LOT#: 0458549W, 510K#: K152277, UDI# (B)(4), QTY# 1. ALTHOUGH IT IS UNKNOWN WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-5 USING A INTERBODY SPACER AND PIVOX PLATE WITH SCREWS DUE TO DEGENERATIVE DISC DISEASE STENOSIS. INTRA-OPERATIVELY, THE PATIENT HAD VENOUS BLEEDING . THE IMPLANTATION WENT AS PLANNED. AFTER CONFIRMATION THAT THE IMPLANTS WERE PROPERLY POSITIONED THE EXPOSING SURGEON HAD VENOUS BLEEDING WHICH ESCALATED TO BRISK BLEEDING FROM THE VENA CAVA. THE PATIENT LOST A GREAT DEAL OF BLOOD AND THE BLEEDING WAS HEAVY. AS PER THE UNDERSTANDING THE VENA CAVA WAS STAPLED OFF AND THE WOUND WAS CLOSED. THEN BILATERAL FASCIOTOMIES WAS PERFORMED ON THE LEGS. THE PATIENT WAS BROUGHT BACK TO THE OR FOR BILATERAL THROMBECTOMIES. AS PER THE REP'S UNDERSTANDING THAT THE PATIENT PASSED AWAY THURSDAY NIGHT OR EARLY FRIDAY MORNING. THE REP DID NOT BELIEVE THAT IT HAS BEEN DETERMINED HOW OR WHAT CAUSED THE VENOUS INJURY. PATIENT DEATH OCCURRED AS THE RESULT OF VENOUS INJURY AT THE END OF AN OLIF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283136 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O