BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERO LL FIXATION ANCHOR, 50MM

    MDR report key: 8447952 · Received March 25, 2019

    Report

    Report Number
    0009617544-2019-00034
    Event Type
    Malfunction
    Date Received
    March 25, 2019
    Date of Event
    February 28, 2019
    Report Date
    January 13, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    OVD
    UDI-DI
    07613327066173
    PMA / PMN Number
    K151726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO G.5. (510K): UPDATED FROM K142066 TO K151726 VISUAL INSPECTION CONFIRMED THAT TIP OF THE ANCHOR WAS DEFORMED. MATERIAL ANALYSIS CONCLUDED THE MEASURED HARDNESS OF THE CUTTER WAS FOUND TO MEET THE REQUIREMENTS ON THE PRINT. THE OBSERVED ELEMENTAL CONSTITUENTS WERE FOUND TO MEET THE PRINT REQUIREMENTS FOR THE CUTTER AND THE BLADES. NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. DEVICE AND COMPLAINT HISTORY RECORDS WERE REVIEWED, AND NO RELEVANT MANUFACTURING OR SIMILAR COMPLAINTS WERE IDENTIFIED. PER SURGICAL TECHNIQUE: 1. TITANIUM ANCHORS, WHICH ARE GUIDED THROUGH THE CAGE, ENGAGE WITH THE PROXIMAL AND DISTAL ASPECTS OF THE IMPLANT, AND LOCK INTO THE JACKET TO MAXIMIZE SEGMENT STABILITY AND MINIMIZE MICRO-MOTION. 2. THE AERO-LL LUMBAR INTERBODY AND FIXATION SYSTEM MAY BE USED WITH OR WITHOUT THE ANCHOR FIXATION PROVIDED AND MUST BE USED WITH ADDITIONAL SUPPLEMENTAL FIXATION THAT HAS BEEN CLEARED BY THE FDA FOR USE IN THE LUMBOSACRAL SPINE. 3. USE THE PILOT CUTTER TO PERFORATE THE CORTEX AND CREATE CHANNELS FOR THE ANCHORS. 4. USING THE MALLET, TAP THE PILOT CUTTER GENTLY TO PENETRATE THE CORTEX AND CREATE A CHANNEL. A BUILT-IN DEPTH STOP ON THE PROXIMAL END OF THE INSERTER GUIDE LIMITS THE DEPTH OF THE PILOT CUTTER INSERTION. 5. REMOVE THE PILOT CUTTER FROM THE VERTEBRAL BODY BY GENTLY TAPPING THE CUTTER BACK OUT OF THE VERTEBRAL BODY. WITH THE PILOT CUT MADE, INSERT AN ANCHOR INTO THE SAME CHANNEL ON THE INSERTER GUIDE AND INTO THE VERTEBRAL BODY AS SHOWN IN THE ANCHOR INSERTION STEP. ONCE THE FIRST ANCHOR IS PLACED AND LOCKED INTO THE JACKET OF THE CAGE, USE THE SAME METHODOLOGY WITH THE PILOT CUTTER AND INSERTER GUIDE TO CREATE REMAINING CHANNEL AND PLACE THE REMAINING ANCHORS. ANCHOR INSERTION: 1. PULL THE ANCHOR CARTRIDGE FROM THE TRAY AND MANUALLY LOAD INTO THE GROOVE OF THE INSERTER GUIDE. DOWNWARD PRESSURE ONTO THE ANCHOR CARTRIDGE RELEASES THE ANCHOR FROM THE ANCHOR CARTRIDGE. 2. INSERT THE ANCHOR TAMP INTO THE GROOVE OF THE INSERTER GUIDE AND SLIDE DOWNWARD UNTIL IT INTERFACES WITH A NOTCH ON THE ANCHOR. USING THE MALLET, TAP THE ANCHOR TAMP TO ADVANCE THE ANCHOR THROUGH THE CORTEX OF THE VERTEBRAL BODY AND ENGAGE INTO THE JACKET. PER COMMUNICATION WITH STRYKER SALES REPRESENTATIVE, PATIENT HAD CONCRETE BONE QUALITY AND SURGEON ATTRIBUTED MUCH OF THE EVENT TO BONE QUALITY OF THE PATIENT. RISK TABLE STATES THAT TOO MUCH INSERTION FORCE APPLIED TO INSTALL ANCHOR CAN RESULT IN ANCHOR DAMAGE. BASED ON AVAILABLE INFORMATION, MOST LIKELY CAUSE OF REPORTED EVENT IS PATIENT'S HARD BONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANCHOR WAS DAMAGED(BENT UPWARD) WHILE INSERTING AT L3 VERTEBRAE. THE SURGEON REMOVED THE ANCHOR AND TRIED USING SECOND ANCHOR WHICH WAS DEFORMED AGAIN. THE SURGEON DECIDED NOT TO PLACE BLADE ON THE SUPERIOR LEVEL. THE SURGEON WAS CONTENT WITH THE AMOUNT OF FIXATION AND COMPLETED SURGERY SUCCESSFULLY (FACET FUSION WITH MICRO DECOMPRESSION ON THE POSTERIOR SIDE) USING ANOTHER ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD CONCRETE BONE QUALITY AND THE SURGEON ATTRIBUTED MUCH OF EVENT TO THE BONE QUALITY OF THE PATIENT. A SURGICAL DELAY OF CLOSE TO AN HOUR WAS REPORTED. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR WAS DAMAGED(BENT UPWARD) WHILE INSERTING AT L3 VERTEBRAE. THE SURGEON REMOVED THE ANCHOR AND TRIED USING SECOND ANCHOR WHICH WAS DEFORMED AGAIN. THE SURGEON DECIDED NOT TO PLACE BLADE ON THE SUPERIOR LEVEL. THE SURGEON WAS CONTENT WITH THE AMOUNT OF FIXATION AND COMPLETED SURGERY SUCCESSFULLY (FACET FUSION WITH MICRO DECOMPRESSION ON THE POSTERIOR SIDE) USING ANOTHER ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT HAD CONCRETE BONE QUALITY AND THE SURGEON ATTRIBUTED MUCH OF EVENT TO THE BONE QUALITY OF THE PATIENT. A SURGICAL DELAY OF CLOSE TO AN HOUR WAS REPORTED. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241131 AERO LL FIXATION ANCHOR, 50MM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD STRYKER SPINE-US 14G499 07613327066173

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR