BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETFUSE SCREWS

    MDR report key: 3020986 · Received March 20, 2013

    Report

    Report Number
    3005977257-2013-00010
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 9, 2009
    Report Date
    March 13, 2013
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING INVESTIGATION THAT PT REVISION REVEALED DELAYED/NON-UNION OF THE FACET JOINT FUSION. RISK ASSOCIATED WITH DEVICE PERFORMANCE WHEN SUBJECTED TO NON-UNION ARE SUFFICIENTLY ADDRESSED IN DEVICE LABELING. IT WAS ALSO REPORTED BY SPINFRONTIER CLINICAL PERSONNEL, WHO ASSESSED THE PT'S CONDITION PRIOR TO IMPLANT, THAT IT WAS RECOMMENDED THAT THE FACET FIXATION BE MADE IN CONJUNCTION WITH AN INTERVERTEBRAL BODY FUSION (IBF) DEVICE. THE FIXATION WAS NOT PERFORMED ACCORDINGLY AND, THEREFORE, THE FACET SCREWS WERE LIKELY EXPOSED TO HIGHER LOAD BEARING FORCES THAN THEY WOULD HAVE IN CONJUNCTION WITH AN IBF DEVICE. FACETFUSE PACKAGE INSERT INDICATES THAT "INTERNAL FIXATION APPLIANCES ARE LOAD SHARING DEVICES WHICH ARE USED TO OBTAIN ALIGNMENT UNTIL NORMAL HEALING OCCURS". THIS INDICATES THAT THE DEVICE IS INTENDED AS A TEMPORARY SOLUTION UNTIL FUSION OCCURS.

    Description of Event or Problem · 1

    NOTE: A FULL AUDIT OF ALL LEGACY COMPLAINTS SINCE THE INCEPTION OF THE COMPANY (2007) WAS CONDUCTED TO ASSURE ANY NON-CONFORMITIES THAT MAY EXIST FROM EARLIER YEARS WERE DISCOVERED AND PROPERLY DOCUMENTED AND ADDRESSED. DURING THE AUDIT THIS REPORTABLE EVENT WAS IDENTIFIED AND IS NOW BEING SUBMITTED. PREVIOUS PERSONNEL HAD DEEMED THIS A NON-REPORTABLE. THIS EVENT WAS TO BE REPORTED WITHIN 30 DAYS OF OCCURING. FACETFUSE SCREWS WERE IMPLANTED INTO A PT ON (B)(6) 2008. ON (B)(6) 2009, THE IMPLANTING SURGEON COMMUNICATED THAT DURING PT FOLLOW UP IT WAS NOTED THAT TWO FACETFUSE SCREWS HAD PULLED OUT OF THE IMPLANT SITE. THE PT WAS REVISED AND IT WAS NOTED DURING REVISION THAT THERE WAS DELAYED FUSION OR NON-UNION OF THE FACET JOINTS. GENERAL PT INFO: ELDERLY MALE WITH DEGENERATIVE DISC DISEASE AND POOR BONE QUALITY, REQUIRING FIXATION/FUSION AT L4-L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116171 FACETFUSE SCREWS FACET SCREWS MRW SPINEFRONTIER, INC. IM0006 92906

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention