BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE, SELF TAPPING HEXALOBE SCREW (TI-6AL-4V ELI)

    MDR report key: 5237568 · Received November 19, 2015

    Report

    Report Number
    2027467-2015-00193
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    September 2, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EXAMINING THE POST-OPERATIVE X-RAYS, THE RETURNED IMPLANTS, AND A REVIEW OF THE TRESTLE LUXE ENGINEERING DRAWINGS AS WELL AS THE RISK MANAGEMENT FILE, THE MOST LIKELY ROOT CAUSE OF THIS FAILURE WAS SUBSIDENCE/UNDESIRED MOVEMENT OF THE PATIENT ANATOMY LEADING TO UNDUE STRESS ON THE FAR SUPERIOR AND INFERIOR SCREWS. EXAMINING THE POST-OPERATIVE X-RAY, THE FAR INFERIOR SCREWS APPEAR TO BE ANGLED BEYOND THEIR STEEPEST ALLOWABLE ANGLE OF 9° FROM NEUTRAL. HOWEVER, IN LOOKING AT THE PARTS RETURNED AND IMAGES PROVIDED, THOSE SCREW HAVE SHIFTED THEIR POSITION TO BE CLOSER TO A NEUTRAL ANGLE, INDICATING THAT EITHER THE PLATE MOVED DOWN, OR THE FAR INFERIOR PATENT ANATOMY MOVED UP. IT IS IMPORTANT TO ALSO NOTE, THAT THESE INFERIOR SCREWS ARE STILL FIXATED INSIDE THE PLATE DUE TO BONY INGROWTH, NEGATING THE POSSIBILITY OF THEM HAVING MOVED AFTER THEIR REMOVAL. IMAGE ONE SHOWS THE POST-OPERATIVE SCREWS AND ANGLES COMPARED TO THE ANGLES AFTER THE PLATE WAS REMOVED. THE TRESTLE LUXE SYSTEM IS INDICATED FOR A SHELF LIFE OF 2 YEARS AFTER IMPLANTATION AS DESCRIBED IN REC-001579 "USEFUL PRODUCT LIFE (IMPLANTS & INSTRUMENTS)". THIS SHELF LIFE WAS DETERMINED TO BE ADEQUATE AND THE TRESTLE LUXE SYSTEM WAS ABLE TO SHOW THAT IT CAN MEET THIS REQUIREMENT VIA THE EXECUTION OF ASTM MECHANICAL TESTING. THIS TESTING IS INTENDED TO SIMULATE THE CONSTRUCT IN A VERTEBRECTOMY MODEL IN ORDER TO ADEQUATELY SHOW THAT IT IS STRONG ENOUGH TO PROVIDE TEMPORARY FIXATION UNTIL A FUSION OCCURS. PER THE RESULTS PRESENTED IN REC-000937, REC-000938, & REC-000939, THE TRESTLE LUXE PLATE AND SCREW CONSTRUCT WAS ABLE TO MEET ALL ACCEPTANCE CRITERIA AND ENSURE THAT IT IS STRONG ENOUGH TO WITHSTAND THE STATIC AND DYNAMIC FORCES REQUIRED TO PROVIDE THIS TEMPORARY FIXATION FOR A FUSION MASS TO FORM. PROVIDED THAT THE SCREW ANGLES FROM IMPLANTATION TO PRESENT STATE HAVE SHIFTED AND ALSO THAT THE CENTRAL FOUR SCREWS SHOW NO SIGNS OF DAMAGE OR BREAKAGE, IT IS MOST LIKELY THAT THE PATIENT ANATOMY SHIFTED CAUSING AN INCREASED STRESS ON THE FAR INFERIOR AND SUPERIOR SCREWS LEADING TO THE BREAKAGE AND FAILURE OF THE CONSTRUCT AND POSSIBLY CAUSING THE FAILURE OF A FUSION MASS TO OCCUR.

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED THE ENTIRE EXPLANTED CONSTRUCT CONSISTING OF 1 PLATE AND 6 SCREWS TO ALPHATEC FOR EVALUATION. ALL THE RETURNED IMPLANTS WERE ABLE TO BE IDENTIFIED EXCEPT FOR THE 4 BROKEN SCREWS. THE PROXIMAL SECTIONS OF THE SCREW HEAD WHICH CONTAIN THE IDENTIFYING PART AND LOT NUMBER HAVE BEEN MANIPULATED AND DEFORMED TO THE POINT IDENTIFICATION IS ILLEGIBLE. 71003-057; ANTERIOR CERVICAL PLATE ASSEMBLY, 3-LEVEL, 057MM - LOT# 681336, MFG'D 9/30/14. 71340-14; 4.0MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14MM -LOT# 680950, MFG'D 10/8/14. 71340-14; 4.0MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14MM - LOT# 680951, MFG'D 10/7/14. THE TRESTLE LUXE CONSTRUCT IS CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    ALPHATEC RECEIVED MEDWATCH REPORT NUMBER MW5056207 INDICATING REVISION SURGERY CONDUCTED (B)(6) 2015 TO REMOVE A 3-LEVEL TRESTLE LUXE PLATE AND 6 SCREWS. THE OCCURRENCE WAS FOUND ALONG WITH NON-UNION OF C4/C5 AND C6/C7 THAT 2 SCREWS AT C4 LEVEL, 2 SCREWS AT C7 LEVEL WERE BROKEN. THE BENT PLATE WAS AND SIX SCREWS WERE REMOVED WITH THE EXCEPTION OF THE DISTAL SECTION OF 4 SCREWS WHICH REMAIN IMBEDDED IN C4 AND C7. THE TRESTLE LUXE PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767689 VARIABLE ANGLE, SELF TAPPING HEXALOBE SCREW (TI-6AL-4V ELI) SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization