BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSTIQUE GRAFT CONTAINMENT PLATING SYSTEM

    MDR report key: 2092593 · Received May 5, 2011

    Report

    Report Number
    2530154-2011-00001
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    December 25, 2009
    Report Date
    May 4, 2011
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    KWQ
    PMA / PMN Number
    K041105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DESIGN HISTORY RECORDS REVIEWED. ADD'L CLINICAL INFO REQUESTED. RESULTS OF THE COMPLAINT INVESTIGATION WILL BE REPORTED IN A F/U MDR REPORT FILING. ADD'L MODEL #6653113, ADD'L LOT #S 79097, 76675, ADD'L DEVICE MFR DATES: 11/2008 AND 2/2009.

    Description of Event or Problem · 1

    A PT HAD ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY AT C3/C4 USING MYSTIQUE PLATING SYS, CONSISTING OF A 25MM PLATE AND 4 SCREWS, TO RELIEVE CHRONIC NECK AND ARM PAIN IN (B)(6) 2009. AT SOME POINT POST-OPERATIVELY, THE PT BEGAN TO DEVELOP SYMPTOMS CONSISTENT WITH HIS PRE-SURGICAL CONDITION. APPROX 2 MONTHS POST-OPERATIVE, THE PT COUGHED UP A SURGICAL SCREW. APPROX 2 WEEKS LATER, A SECOND SURGERY WAS PERFORMED AND THE MYSTIQUE PLATING SYS, BONE GRAFT AND SCREWS WERE REMOVED. APPROX 4 DAYS LATER, THE PT EXPERIENCED PARALYSIS. MR IMAGING REVEALED ABSCESSES IN THE PT'S CERVICAL SPINE CANAL, CAUSING SPINAL CORD COMPRESSION. SURGERY WAS IMMEDIATELY PERFORMED TO DRAIN THE ABSCESSES AND THE INFECTION WAS SUBSEQUENTLY CURED. HOWEVER, THE PARALYSIS APPEARS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYSTIQUE GRAFT CONTAINMENT PLATING SYSTEM KWQ - APPLICANCE, FIXATION, SPINAL KWQ KENSEY NASH CORP. 6651125 79507

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability