BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-JAWS

    MDR report key: 1103064 · Received August 1, 2008

    Report

    Report Number
    1000432246-2008-00002
    Event Type
    Injury
    Date Received
    August 1, 2008
    Report Date
    July 31, 2008
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    KWP
    PMA / PMN Number
    K062181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE BEGINNING OF (2006) OF THE LAUNCH OF C-JAWS ON THE MARKET (WORLDWIDE), THE POST-MARKET SURVEY OF THIS DEVICE SHOWS THE FOLLOWING RESULTS: 1.3 % OF IMPLANTED C-JAWS WERE BACK-OUT DUE TO NO RESPECT OF INDICATIONS; 0.4 % OF IMPLANT C-JAWS WERE BACK-OUT DUE TO NON RESPECT OF THE SURGICAL TECHNIQUE; 0.4 % OF IMPLANTED C-JAWS WERE BACK-OUT DUE TO CLINICAL REASONS OF THE PTS; 0.3 % OF IMPLANTED C-JAWS WERE BACK OUT WITH NOT ENOUGH INFO TO CONCLUDE. THESE RATES ARE ACCEPTABLE IN THE ORTHOPAEDIC FIELD. BACK-OUTS ARE POSSIBLE UNDESIRABLE EFFECTS WHICH ARE DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IN 2008, SALES REP REPORTS 3 CASES OF BACK OUT OF THE IMPLANT. NO INFO ABOUT THE PT, NO INFO ABOUT THE PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1