BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-JAWS

    MDR report key: 974595 · Received January 7, 2008

    Report

    Report Number
    1000432246-2007-00003
    Event Type
    Injury
    Date Received
    January 7, 2008
    Date of Event
    November 26, 2007
    Report Date
    December 20, 2007
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    KWP
    PMA / PMN Number
    K062181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS: DEVICE MFG AND CONTROL BATCH RECORD WAS REVIEWED: NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON CONFORMANCE TO SPECIFICATIONS. THE IMPLANT WAS NOT AVAILABLE FOR EXAMINATION AND EVALUATION BUT X-RAYS DON'T SHOW ANY DAMAGE OR FAILURE OF THE DEVICE. THE SURGEON WHO IS A CURRENT USER OF THE DEVICE DOESN'T EXPLAIN HOW THAT EVENT COULD HAPPEN. HE SUSPECTS THE POOR QUALITY OF BONE OF THE PATIENT WHICH IS A SMOKER. HE WASN'T AWARE OF THE OSTEOPOROSIS OF THE PATIENT WHEN HE DID THE SURGERY. OSTEOPOROSIS IS A CONTRA INDICATION TO THE USE OF A C-JAWS IMPLANT AND IT IS DESCRIBED IN THE IFU. SURGEON ALSO REPORTED MULTIPLE HYPEREXTENSION MANOEUVRES OF THE FEMALE PATIENT DUE TO THE KICKING IN HER FACE A COUPLE OF TIME BY HER BABY. ACCORDING TO THE SURGEON AND MEDICREA, THE DEVICE SEEMS TO BE WELL SEATED EVEN IF IT COULD HAVE BEEN MORE IMPACTED (SUPERIOR CONNECT). MEDICREA HAVEN'T SEEN X-RAYS PRE AND PER OP TO BE TOTALLY ASSURED THAT THE DEVICE HAS BEEN CORRECTLY SET UP. SURGICAL TECHNIQUE HAS NOT BEEN FULLY RESPECTED AS THE C-JAWS WAS NOT USED IN A COMBINATION WITH A RIGID POSTERIOR CERVICAL FIXATION. CONCLUSION: THIS PROBLEM MIGHT BE RELATED TO THE POOR QUALITY OF BONE OF THE PATIENT, TO THE NON RESPECT OF THE SURGICAL TECHNIQUE, AND IT CAN BE ALSO DISCUSSED THE QUALITY OF THE BONE GRAFT USED AS INTERBODY FUSION DEVICE. THE REPORTED INCIDENT IS NOT A PRODUCT RELATED FAILURE AND DOES NOT QUESTION EFFICIENCY OF THE C-JAWS PRODUCT.

    Description of Event or Problem · 1

    IMPLANT PARTIALLY PULLED OUT: THE SURGERY TOOK PLACE IN 2007 FOR A DEGENERATIVE C5/C6 STAPLE FUSION WITH DENS CANCELLOUS BONE. THE POST OPERATION VISIT, FOURTEEN DAYS LATER, APPEARS STILL CONFORM. ON THE FOLLOW UP VISIT OF THE FOLLOWING MONTH, X-RAY INDICATES TWO TEETH OF C-JAWS IMPLANT PULLED OUT OF THE BONE OF THE SUPERIOR AND INFERIOR VERTEBRAE. THERE ARE TWO TINES ON BOTH SIDES THAT ARE NOT EMBEDDED IN BONE. EXAMINATION OF PATIENT: BONE GRAFT APPEARS TO BE INCORPORATED, AXIAL ROTATION RIGHT/LEFT (HEAD) IS ABOUT SIXTY DEGREES, NO PAIN WITH HEAD COMPRESSION, THERE IS GOOD MOTOR STRENGTH IN THE UPPER EXTREMITIES, SHE HAD SOME DYSPHAGIA AND DISCOMFORT TO SWALLOW, ASSOCIATED INCREASING LOW BACK PAIN, SHE IS NEUROLOGICALLY INTACT. THE SURGEON WANTS THE PATIENT TO PROCEED WITH EXPLORATION OF THE CERVICAL FUSION AND REMOVAL OF THE C-JAWS IMPLANT.

    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 42 YR Hospitalization| R