BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-JAWS

    MDR report key: 935677 · Received May 25, 2007

    Report

    Report Number
    1000432246-2007-00001
    Event Type
    Injury
    Date Received
    May 25, 2007
    Date of Event
    April 27, 2007
    Report Date
    May 24, 2007
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    KWP
    PMA / PMN Number
    K062181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS COMPLETE: 1-DEVICE HISTORY RECORD (DHR) WAS REVIEWED: NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. TWO-EXAMINATION OF EXPLANTED DEVICE DID NOT SHOW EVIDENCE OF DEVICE MALFUNCTION OR FAILURE. BASED ON THE INVESTIGATIONAL FINDINGS, MEDICREA CONSIDERS THE INVESTIGATION CLOSED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IMPLANT BACK OUT: AFTER THE FIRST SURGERY (2007), THE PATIENT RETURNED FOR FOLLOW-UP EXAM. ON THE FOLLOW-UP X-RAY, THE C-JAWS WAS DETECTED TO BE EXTRACTED EXCEPT FOR ONE TIME. IF WAS HANGING BY THE LAST TOOTH. BEFORE THIS FOLLOW-UP, THE PATIENT HAD NO ADVERSE EVENTS. X-RAY AND REMOVAL OF THE IMPLANT WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-JAWS ANTERIOR CERVICAL BUTTRESS PLATE KWP MEDICREA TECHNOLOGIES 06I0262

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DEPUY CARBON FIBER CERVICAL CAGE