BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERTE-STACK K030736, K041197

    MDR report key: 8222063 · Received January 4, 2019

    Report

    Report Number
    MW5082855
    Event Type
    Death
    Date Received
    January 4, 2019
    Date of Event
    June 7, 2004
    Report Date
    January 2, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CASE STUDY INVOLVING 15 HUMAN SUBJECTS UNDERGOING COMBINATION OF RHBMP 2 AND ASSEMBLED VERTE-STACK COMPONENTS K03736, K041197 FOLLOWING ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF). ONE PT FATALITY (DEATH) FOLLOWING POST-OP ASPIRATION PNEUMONIA. ANOTHER PT REQUIRED POSTERIOR REVISION SURGERY, REPORTED FOLLOWING POST-OP GRAFT (DEVICE) MIGRATION. ONE CASE OF EXCESS BONE GROWTH. STUDY PTS NOT INFORMED VERTE-STACK LABELED DEVICES ARE LABELED CONTRAINDICATED FOR CERVICAL USE. [(B)(4)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9783 VERTE-STACK K030736, K041197 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 627XXXX ENDCAPS
    9784 VERTE-STACK K030736, K041197 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 627XXXX STRUT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| O| R