BEUDAMED
    FDA Adverse Event Summary report: N

    PRO DISC

    MDR report key: 2431071 · Received January 19, 2012

    Report

    Report Number
    2431071
    Date Received
    January 19, 2012
    Date of Event
    December 26, 2011
    Report Date
    January 19, 2012
    Manufacturer
    SYNTHES USA PRODUCTS LLC
    Product Code
    MJO
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE SURGEON'S OPERATIVE NOTE: THE PATIENT "UNDERWENT A CERVICAL ARTHROPLASTY TWO MONTHS AGO. HE DID WELL AT HIS FOLLOWUP VISIT THREE WEEKS POSTOPERATIVE. HE HAD MINIMAL SYMPTOMS WITH THE EXCEPTIONS OF MILD ACHINESS IN THE NECK. HE STATES THAT APPROXIMATELY 2 TO 3 WEEKS AGO, HE DEVELOPED SEVERE CERVICAL PAIN WITH MARKEDLY WORSENING HAD BEFORE. X-RAYS WERE DONE, WHICH SHOWED ANTERIOR DISPLACEMENT OF THE ARTHROPLASTY. HE DENIES A FALL. DID REVIEWED THE FILMS AS WELL AS THE INTRAOPERATIVE FILMS. INTRAOPERATIVE FILM SHOWED THAT THE ARTHROPLASTY BE CLEARLY RECESSED IN THE DISK SPACE WITH A GOOD ANTERIOR MARGIN OF BONE. CURRENT FILMS SHOWED THAT IT IS DISPLACED ANTERIORLY 3 TO 4 MM. THE PATIENT IS BEING TAKEN TO SURGERY FOR A REMOVAL OF THE ARTHROPLASTY AND CONVERSION TO A FUSION." ALSO IN THE OPERATIVE NOTE: "THE ARTIFICIAL DISK WAS IDENTIFIED. THERE WAS NO FRACTURE IN THE SUPERIOR OR INFERIOR ASPECTS OF THE KEELS. DISTRACTION PINS WERE SCREWED INTO THE BODY OF C5 AND C6 AND DISTRACTION WAS PLACED ACROSS THE ARTHROPLASTY. IT WAS THEN REMOVED USING A KOCHER RONGEURS." "THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO DISC ARTIFICIAL CERVICAL DISC MJO SYNTHES USA PRODUCTS LLC * 6688184

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR