BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-JAWS

    MDR report key: 1103063 · Received August 1, 2008

    Report

    Report Number
    1000432246-2008-00001
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE BEGINNING (2006) OF THE LAUNCH OF C-JAWS ON THE MARKET (WORLDWIDE) THE POST-MARKET SURVEY OF THIS DEVICE SHOWS THE FOLLOWING RESULTS: 4.3% OF IMPLANTED C-JAWS WERE BROKE DUE TO NOT FOLLOWING INDICATION; 0.6 % OF IMPLANTED C-JAWS WERE BROKE DUE TO NOT FOLLOWING THE SURGICAL TECHNIQUE; 0.4 % OF IMPLANTED C-JAWS WERE BROKE DUE TO CLINICAL REASONS OF THE PTS; 1.4% OF IMPLANTED C-JAWS WERE BROKE WITH NOT ENOUGH INFO TO CONCLUDE. THESE RATES ARE ACCEPTABLE IN THE ORTHOPAEDIC FIELD. BREAKAGES ARE POSSIBLE UNDESIRABLE EFFECTS WHICH ARE DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IN 2008, SALES REP REPORT 4 CASES OF BREAKAGE OF IMPLANT. NO INFO ABOUT THE PTS, NO INFO ABOUT THE PRODS.

    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