BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHAMELEON FACETFUSE MIS SCREW SYSTEM

    MDR report key: 1939768 · Received December 17, 2010

    Report

    Report Number
    3005977257-2010-00003
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MRW
    PMA / PMN Number
    K071420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND WAS FOUND TO MEET QUALITY REQUIREMENTS. THE PT IS A (B)(6) MALE WHO (B)(6). DEVICE LABELING WAS REVIEWED AND IT IS NOTED THAT WARNING 4B IN THE PACKAGE INSERT WARNS THAT "AN OVERWEIGHT OR OBESE PT CAN PRODUCE LOADS ON THE DEVICE WHICH CAN LEAD TO FAILURE OF THE APPLIANCE AND THE OPERATION." ADDITIONAL INFORMATION IS PROVIDED IN THE DEVICE LABELING INSTRUCTING THE PT ABOUT THEIR POST-OP ACTIVITIES. AN ADDITIONAL WARNING (WARNING #2) IS PROVIDED IN LABELING THAT THE DEVICE, IF SUBJECTED TO INCREASED LOAD, WILL FATIGUE AND MAY EVENTUALLY BREAK THE IMPLANT. IT HAS BEEN CONCLUDED THAT THE DEVICE WAS UTILIZED IN A CONTRAINDICATED MANNER. DEVICE EVALUATION SUMMARY: THE SHEARED FACETFUSE SCREW FROM THIS EVENT WAS REC'D ON 11/29/2010 AND SUBSEQUENTLY EVALUATED BY THE ENGINEERING AND QUALITY TEAMS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT IT SHEARED AT THE THREADED PORTION TOWARD THE LAG OF THE SCREW. IT WAS OBSERVED THAT THE SHEARING OF THE DEVICE IS CONSISTENT WITH FAILURE MODES OBSERVED DURING CANTILEVER BEND PEAK LOADING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RETURNED TO THE HOSPITAL APPROX 1.5 MONTHS POST-OP COMPLAINING OF BACK PAIN. THE PT HAD REC'D A FACET FUSION USING THE CHAMELEON FACETFUSE MIS SCREW SYSTEM AND AN INTERBODY FUSION USING A COMPETITOR'S DEVICE. UPON EXAMINATION, IT WAS FOUND THAT ONE OF THE FACETFUSE SCREWS HAD SHEARED. THE PT WAS REVISED, WITH THE TOP PORTION OF THE SCREW BEING REMOVED AND THE LOWER HALF REMAINING IN THE VERTEBRAL BODY. THE PT WAS REVISED WITH PEDICLE SCREWS AND WAS REPORTED TO HAVE NO RESULTING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHAMELEON FACETFUSE MIS SCREW SYSTEM MRW SPINEFRONTIER, INC. IM0055-06 W23212/1

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention