BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    MDR report key: 7913709 · Received September 27, 2018

    Report

    Report Number
    1030489-2018-01297
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 27, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (1) PRODUCT ID: 7770723, LOT: 0514642W, 510(K): K172199, UDI: (B)(4), QUANTITY: 01; (2) PRODUCT ID: 6430530, LOT: 0593585W, 510(K): K143375, UDI: (B)(4), QUANTITY: 01; (3) PRODUCT ID: 54750016545, LOT: H5422123, 510(K): K143375, UDI: (B)(4), QUANTITY: 04; (4) PRODUCT ID: 641100050, LOT: 0420224W, 510(K): K143375, UDI: (B)(4), QUANTITY: 01; (5) PRODUCT ID: 641100055, LOT: 0409967W, 510(K): K143375, UDI: (B)(4), QUANTITY: 01; (6) PRODUCT ID: 1664017, LOT: 0648676W, QUANTITY: 01 (THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 6430530, 510K# K143375 AND UDI (B)(4) IS APPROVED FOR SALE IN US.); (7) PRODUCT ID: 7600105, LOT: 215150530, 510(K): K082918, UDI: (B)(4), QUANTITY: 01. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS 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 LUMBAR INTERBODY FUSION AND PERCUTANEOUS SCREW FIXATION AT LEVEL L4-5 DUE TO LUMBAR SPINAL CANAL STENOSIS. IN ADDITION, AUTOGENOUS BONE AND GRAFT WERE MIXED INTO GRAFTED BONE AND IT WAS INSERTED INTO INTERVERTEBRAL SPACE. NO PROBLEM WITH MEP WAS OBSERVED DURING AND AFTER THE OPERATION. AFTER 4-5 HOURS OF OPERATION, PARALYSIS BECAME WORSE THAN PRE-OP. CT IMAGING WAS TAKEN IMMEDIATELY TO CHECK IMPLANT POSITION AND IT WAS CONFIRMED THAT ALL THE IMPLANTS WERE PLACED IN PROPER POSITION. THE NEXT DAY, WHEN MRI IMAGING WAS PERFORMED, SHADOWS LIKE HEMATOMA WERE FOUND OUTSIDE DURA. FROM THE NEXT DAY, DEGREE OF PARALYSIS BECAME LIGHTER, SO IT WAS DECIDED TO OBSERVE THE STATE. A WEEK AFTER THE OPERATION, CONDITION OF THE PATIENT WAS REPORTED TO BE BECAME BETTER THAN THE PRE-OPERATIVE CONDITION, AND THE PATIENT IS ALSO SATISFIED WITH IT. IN THE OPINION OF THE PHYSICIAN, THE ADVERSE EVENT WAS NOT CAUSED BY THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758056 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other