BEUDAMED
    FDA Adverse Event Death Summary report: N

    1030489-2019-01511

    MDR report key: 9536156 · Received December 31, 2019

    Report

    Report Number
    1030489-2019-01511
    Event Type
    Death
    Date Received
    December 31, 2019
    Date of Event
    November 22, 2019
    Report Date
    December 31, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: CX01B, LOT: UNKNOWN, 510(K): K163032, UDI: (B)(4), QTY: 2, PRODUCT CODE: NDN, IMPLANT DATE: (B)(6) 2019. PRODUCT ID: KPX153RB, LOT: UNKNOWN, 510(K): K101864, UDI: (B)(4), QTY: 1, PRODUCT CODE: HRX, NOT IMPLANTABLE. 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 A COMPLEX SPINE PROCEDURE WITH ESTIMATED TIME OF 13 HOURS CONSISTING HARDWARE REMOVAL SURGERY, POSTERIOR SPINE FUSION AND 2-LEVEL KYPHOPLASTY AT T9-T10. AFTER THE PROCEDURE, THE PATIENT WAS FLIPPED AND EXTUBATED. THE PATIENT DID NOT WAKE UP; AND EXPIRED. THE REASON FOR PATIENT DEATH IS REPORTED TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329766 NDN MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death