BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPPERHEAD CERVICAL INTERBODY CAGE

    MDR report key: 5366248 · Received January 8, 2016

    Report

    Report Number
    MW5059324
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 11, 2012
    Report Date
    January 8, 2016
    Manufacturer
    EMINENT SPINE
    Product Code
    ODP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHIN ET AL. (2012) "WHITE CORD SYNDROME" OF ACUTE TETRAPLEGIA AFTER ANTERIOR CERVICAL DECOMPRESSION AND FUSION FOR CHRONIC SPINAL CORD COMPRESSION" A CASE REPORT" REPORTS THAT A (B)(6) MALE SUFFERED INTRAOPERATIVE PARAPLEGIA FOLLOWING C4-5 ACDF INVOLVING 8M (H) COPPERHEAD PEEK CERVICAL CAGE (EMINENT SPINE, TEXAS) CLEARED UNDER K090064. PATIENT UNDERWENT REVISION C5 CORPECTOMY WITH UNKNOWN CERVICAL CORPECTOMY CAGE. SLIGHT IMPROVEMENT IN WALKING NOTED, BUT REQUIRES ASSISTIVE FRAME. USER-FACILITY, NOR MANUFACTURER EMINENT SPINE REPORTED THE SERIOUS INJURY AS REQUIRED UNDER 21 CFR 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14954 COPPERHEAD CERVICAL INTERBODY CAGE CERVICAL INTERBODY CAGE ODP EMINENT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| S