BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CERVICAL PLATE

    MDR report key: 5864833 · Received August 8, 2016

    Report

    Report Number
    MW5063949
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    January 12, 2014
    Report Date
    August 8, 2016
    Manufacturer
    CORELINK, LLC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED HE EXPERIENCED AND EXTREME MIGRAINES, NECK PAIN, AND CLICKING WHILE TURNING. HE WENT TO (B)(6) IN (B)(6) 2013 AND WAS REFERRED TO A SPINAL SURGEON. ON (B)(6) 2014 CALLER UNDERWENT A CERVICAL FUSION C4-C7, ANTERIOR CERVICAL PLATE WAS IMPLANTED AND BONE GRAFT PERFORMED. AFTER 15-16 MONTHS, CALLER'S SYMPTOMS RETURNED ALONG WITH GRINDING. HE WENT IN FOR A REVISION SURGERY ON (B)(6) 2015 BUT SURGEON LEFT THE BROKEN PLATE IN CALLER AND ADDED 2 RODS. CALLER IS STILL EXPERIENCING HIS SYMPTOMS, HE IS UNABLE TO PLAY WITH KIDS, KEEP A JOB, OR SLEEP WITH WIFE. CALLER IS IN PURSUIT OF COMPENSATION AND HAS BEEN IN CONTACT WITH LAWYERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506892 ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ CORELINK, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR