BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET

    MDR report key: 1415040 · Received June 29, 2009

    Report

    Report Number
    MW5011959
    Event Type
    Other
    Date Received
    June 29, 2009
    Manufacturer
    BIOMET
    Product Code
    ---
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    POST ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C5-6 AND C6-7 FOR RIGHT ARM SYMPTOMS. SHE WAS STEPPING OFF THE BLEACHERS SHE MISSED A STEP, CAUSING HER TO LAND HARD AND JAR HER SPINE. SINCE THAT TIME SHE HAS HAD LEFT SHOULDER PAIN. SHE DENIES NUMBNESS, TINGLING AND WEAKNESS OF HER UPPER EXTREMITIES. SHE DENIES CHANGES IN BOWEL OR BLADDER HABITS AND DOES NOT HAVE DIFFICULTY BALANCING. IN 2008, X-RAY OF THE CERVICAL SPINE WAS PERFORMED, AT WHICH TIME DR REPORTED THAT "THE BONE GRAFT IS NOT AS WELL VISUALIZED. I CANNOT COMPLETELY EXCLUDE A FRACTURE OF THE C5-6 BONE GRAFT". AT THIS TIME, AN X-RAY WAS OBTAINED OF THE CERVICAL SPINE, WHICH REVEALED A FRACTURED GRAFT AT C5-6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET C5-6 BONE GRAFT --- BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1