BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "BONE EQUIVA 25CC PLATE 38MM"

    MDR report key: 4814854 · Received May 28, 2015

    Report

    Report Number
    MW5042890
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 1

    I HAVE A DISC PROBLEM. MY C4-5 AND C5-6 WERE COMPRESSED. I HAD SURGERY. INCISION WAS MADE IN THE RIGHT ANTERIOR NECK STARTING AT THE MIDLINE, METAL INTERBODY FUSION FOLLOWED BY A TRINICA ANTERIOR CERVICAL PLATE WAS PLACED IN THROUGH MY THROAT. THIS PLATE HAS CAUSED SPURRING IN MY SPINE, BREATHING PROBLEM AND I HAVE TWO KNOTS IN MY THROAT FROM THIS PLATE AND PAIN. OTHER PROBLEM THIS METAL THAT'S IN MY MOUTH: NERVE SPASM, TINGLING IN MY THROAT. DEVICE CLASSIFICATION CLASS II. PRODUCT CODE (5) KWQ, REGULATION NUMBER 21 CFR 888.3060.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER 07/07/2015: DEAR SIR, I AM SENDING COPIES OF THE X-RAYS SHOWING THE PLATE IN MY THROAT. THIS PLATE IS CAUSING A LOT OF PROBLEMS, SWELLING, BREATHING PROBLEM, SOMETHING MOVING IN MY THROAT. SINCERELY, (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON REPORT #MW5042890: DEAR SIR, I SEND IN A CONSUMER VOLUNTARY REPORT (05/28/2015) ABOUT THIS CERVICAL PLATE. THIS EXTENSIVE ARTIFACT ARE INTENDING THE VENTRAL CORD AND I HAVE BILATERAL "PERICARTOID" LYMPH NODES. I NEVER SEEN NOTHING LIKE THIS IN MY LIFE. WHEN WAS A SURGERY SUCH AS THIS APPROVED. DR. (B)(6), MD FROM (B)(6) DID THIS SURGERY. TEL: (B)(6). I MISPLACED THE NUMBER WHEN CHECKING ON THIS ON MY COMPUTER. (B)(6) NEW NUMBER.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON (B)(6) 2015. I SENT THIS X-RAY HOPING THAT FDA RE-EVALUATE THIS METAL PLATE WITH GREAT CONSIDERATION. WHEN THIS PLATE IS PUT NEAR A PERSON'S THROAT IT'S CAUSING TO MANY PROBLEM. I HOPE NO ONE EVER GO THROUGH WHAT I AM EXPERIENCE. THIS PLATE PUSHING IN MY THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344682 "BONE EQUIVA 25CC PLATE 38MM" APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ ZIMMER BIOMET SPINE INC.
    344683 ANTERIOR CERVICAL PLATE KWQ ZIMMER SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability BARIUM SWALLOW| CT| MRI| ULTRASOUND | XRAY| BARIUM SWALLOW| ULTRASOUND| XRAY| MRI| CT