BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK ANATOMIC PEEK STRUT

    MDR report key: 10028419 · Received May 5, 2020

    Report

    Report Number
    MW5094386
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    April 2, 2020
    Report Date
    May 1, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    UDI-DI
    00613994305244
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH BIOLOGIC INFUSE RHBMP-2 USED IN COMBINATION WITH MODULAR VERTE-STACK ANATOMIC PEEK COMPONENTS FOR C5 SINGLE-LEVEL CERVICAL VERTEBRAL BODY REPLACEMENT (CORPECTOMY) AND C4-5/C5-6 ANTERIOR CERVICAL DISCECTOMY AND FUSION. PATIENT WAS NOT INFORMED OF 2008 FDA PUBLIC NOTICE WARNING OF LIFE-THREATENING COMPLICATIONS REFERENCING USE OF RHBMP-2 IN THE CERVICAL SPINE, NOR WAS PATIENT INFORMED THAT USE OF THE VERTE-STACK COMPONENTS IN THE CERVICAL SPINE IS CONTRAINDICATED ON THE DEVICE LABELING CLEARED BY THE FDA [K070173]. HTTPS://WEB.ARCHIVE.ORG/WEB/20160801140944/HTTPS://WWW.FDA.GOV/CDRH/510K/K070173.PDF. STUDIES SHOW RHBMP-2 EXPRESSION ASSOCIATED WITH METASTATIC PROSTATE CANCER PATIENTS [HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/2130271]. IN (B)(6) 2020, PATIENT WAS DIAGNOSED WITH METASTATIC PROSTATIC CANCER EXTRACAPSULAR INVOLVEMENT THROUGH PSA VELOCITY, MRI, FUSION BIOPSY AND HISTOLOGY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486616 VERTE-STACK ANATOMIC PEEK STRUT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 6241041 00613994305244

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| O