BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-JAWS

    MDR report key: 935675 · Received October 18, 2007

    Report

    Report Number
    1000432246-2007-00002
    Event Type
    Injury
    Date Received
    October 18, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    KWP
    PMA / PMN Number
    K062181
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATE POST-OP X-RAY ANALYSIS SHOWS THAT THE C-JAWS DEVICE WAS NOT PROPERLY SEATED ON ANTERIOR WALL OF THE VERTEBRAE AS IS RECOMMENDED IN SURGICAL TECHNIQUE. THE PROTRUSION CREATED BY THE DEVICE MISPLACEMENT IS PROBABLY THE CAUSE OF THE PATIENTS COMPLAINTS. FOLLOW-UP X-RAYS SHOW FEW SIGNS OF FUSION WHICH LEADS TO THINK THE OPERATED SEGMENT MAY STILL BE MOBILE, A SITUATION WHICH WOULD ACCOUNT FOR THE PATIENT'S FEELINGS. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE PATIENT IS A FEMALE NON-SMOKER WITH APPARENT GOOD BONE QUALITY. SHE WAS OPERATED AT LEVEL C6-C7 IN 2007. FUSION WAS PERFORMED AND GRAFT WAS CONTAINED USING A C-JAWS DEVICE. THE PATIENT STARTED COMPLAINING OF DYSPHAGIA IN THREE MONTHS LATER. SHE UNDERWENT SEVERAL COMPLEMENTARY CLINICAL EXAMS TO HELP THE DYSPHAGIA. RADIOLOGICAL EXAMS SHOWED: -A 2.1MM SUBSIDENCE OF THE GRAFT IN THE VERTEBRAL ENDPLATES. -THE C-JAWS DEVICE WAS NOT PROPERLY SEATED AGAINST VERTEBRAE. THESE FINDINGS ACCOUNT FOR THE PATIENT'S COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-JAWS ANTERIOR CERVICAL BUTTRESS PLATE KWP MEDICREA TECHNOLOGIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR