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Interlaminar / Interspinous Dynamic Fusion System - IDF

Facet Joint Fusion System - AFF

Surgical Techniques

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System features

IDF – Interlaminar Interspinous Dynamic Fusion System and AFF – Articular Facets Are designed to promote a better and more efficient intervertebral fusion. Tsunami developed a new manufacturing process capable of offering an excellent environment for spinal fusion thanks to the following aspects: - Osteo integration of the 3D printed titanium; - Benefits of the dynamic fusion process due to the Wolf's Law; - The mesh structure of the implants allows the free flow of bone cells; - The high porosity of its surface supports the settlement and and the growth of new bone formations;

IDF – Interlaminar interspinous Dynamic Fusion System is characterized by: - Central dynamism; - Sintered 3D Titanium; - Available in 4 sizes to perfectly fit the anatomy of the patient; - Adequate height to offer better stability and anchorage to the spinous processes;

Tsunami designed the IDF – Interlaminar Interspinous Dynamic Fusion System is a solution for the treatment of the lumbar stenosis in with you want to reach fusion of the interspinous processes to improve their stability. This procedure shall be performed as open surgery.

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Surgical Techniques

ISCHIA interlaminar Interspinous fusion system

Positioning the patient In order to create slite kyphosis, please place the patient in a prone position with slightly flexed legs. The position of the vertebral levels shall be confirmed via fluoroscopy.

Identifying the target and detach the supra-spinous ligament Perform a median incision on the skin of approximately 4-6 cm. Dissect the paraspinal muscles laterally to the supraspinous ligament. Detach the supra spinous ligament, remove the interspinous ligament. Dissect the ligament from the subperiosteal spinous processes or along a portion of the interspinous process bone, as per the surgeon's preference.

Decompression Whether required - remove a portion of the flavum ligament in order to access the spinal canal and perform the surgical decompression depending upon the patient condition. Alleviate all the neural tension points. A foraminal decompression with a partial laminectomy (micro - opening) may be performed. Whether required, material from the herniated disk may be removed.

Implant home preparation Is important to clean and gently remove the superficial part of the cortical bone where is in contact with the implant to increase the surface of con

!Implant trials Use the implant trials differentiating from one another by 2 mm from 8mm to 14 mm , in order to define the most adequate implant size. A gently distraction of the segment is advisable by introducing the smallest trial of the interspinous spacer. Introduce the trial as anterior as possible, up to the interlaminar space. During the introduction, orient the flat surface of the caudal process of the implant parallel to the lower spinous process. Take extra care while introducing the trials and apply a gentle hammering whether required.

Introducing the trial and verifying its size Remarks: - the right size of the trial implant must show a good press-fit with the spinous process

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Implant Preparation ones the right size of implant has been chosen, you can prepare the implant filling the inner space with bone substitute, bone paste, bone chips or autologous bone. To achieve the right filling of the implant put the IDF on the implant filling base, and fill internal space, if needed use the press tools to compact the biologic material inside the implant. ones the implant is filled, take the ISCHIA on the implant holder and position in the patient interlaminar space

Position ISCHIA on the holder plate

Fill the ISCHIA inner space with biologic material, and press with the instrument

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position ISCHIA on the implant holder

Push ISCHIA inside the interlaminar space, and if necessary use the hammer to locate the implant deeper in the prepared space. Control with the fluoroscope the operation with lateral view, and in AP too.

IMPORTANT TO ALLOW THE CORRECT POSITIONING OF THE INTERLAMINAR INTERSPINOUS DEVICE , YOU MAST RECUPERATE THE LORDOSI PUSHING UP THE LEG OF THE PATIENT BEFOR PROCEED WITH FACET IMPLANTING.

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Articular joint orientation Preliminary to the surgery, use the actual view of the CT scan of the level that you mast treat to have in your mind the direction and orientation of the of the facet joint, Don't forget that this parameter have infinitive variants

Preparing the articular facets Open the capsule.

Remove well the extra soft tissue in order to expose completely the articular facets. Open the capsule and search the interfacet line.

Mobilizing the segment may be required in order to correct identify the entrance for the articular facets.

Using the recurved curet enter in the facet articulation to prepare the space for the rasps.

FILICUDI facets fusion system

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Opening the articular facets

Gently introduce the the art icular facet progressive rasps, and clean the articulation moving up and down. Progressively use larger rasps with the help of the hummer, in order to completely clean the articulation and induct bleeding on the surface.

Rasps are curved and respect the anatomic shape of the facet articulation,

When the facet articulation are clean take the FILICUDI on the implant holder and fill with biologic elements to promote bone grow and facet fusion

FILICUDI is extremely anatomic shape, and the surface is very gripping and aggressive to guarantee a good primary stabilization

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Implanting the articular facets Slide the implant support through the facets. Gentle hammering may be required in order for the implant to reach the exact position of the articular facet to be replaced. Visual verify the implant is completely inside the articular facet and that the insertion stopper reaches the surface to access the articular facet. Please note: - Gently hammer the top of the implant support; - Strong hammering when the implant reaches the final position may brake the articular facet;

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Implanting the second articular facets Is recommended to prepare both the facet articulation space on the same level before implant the FILICUDI fusion system, this will facilitate the correct positioning and the balance of the spine segment.

Repeat all the operation concerning the preparation of the facet articulation and implant of the FILICUDI facet fusion system.

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Instruments

ISCHIA

ISCHIA TRIAL IMPLANT 08 MM ISCHIA TRIAL IMPLANT 10 MM ISCHIA TRIAL IMPLANT 12 MM ISCHIA TRIAL IMPLANT 14 MM

IMPLANT FILLING PLATE

BIOLOGIC MATERIAL COMPACTOR

IMPLANT HOLDER

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FILICUDI

CAPSULA AND LIGAMENT COURVED CUTTER

COURVED FLAT RASPE 1 MM

COURVED RASPE 2 MM

COURVED RASPE 3 MM

COURVED RASPE 5 MM

FILICUDI IMPLANT HOLDER

!IMPORTANT INFORMATION The Interspinous Dynamic Fusion System (IDF) is designed to recreate and maintain the distance between the spinous processes to support the biological fusion in the lumbar or sacral spine. The articular facet (AFF) supports are used as stabiliser of the articular facets with or without bone graft or as fusion support. It should be used as complementary device.DESCRIPTIONThe Interspinous Dynamic Fusion System (IDF) is a device equippped with fixation wings. It is available with several core heights. The device is entirely manufactured in titanium. The Interspinous Device (IDF) is intended to be implanted via Open surgery. The size of the implant depends upon the anatomical conditions and the surgeon’s decision.The components of the Interspinous Dynamic Fusion System (IDF) shall not be used with other spinal or fixation systems. They SHALL NOT be used with other titanium systems and steel prosthesis in the same implant or construct. Any other application of the Interspinous Dynamic Fusion System (IDF) with any other system releases Tsunami for any liability.All the components of the Interspinous Dynamic Fusion System (IDF) shall never be reused under any circumstances. The Interspinous Dynamic Fusion System (IDF) was designed exclusively for posterior approach.MATERIALSThe IDF system is entirely manufactured in medical grade titanium as detailed in the ISO 5832-3, ISO 10993-5, ASTM F2026 and ASTM F136. Tsunami guarantees that every device is manufactured according to the material specifications detailed above. No other warranty, express or implied, is made. Should you require further information, please refer to Tsunami brochure.

INDICATIONSThe Interspinous Dynamic Fusion System (IDF) is intended for the lumbar interspinous decompression and fusion for the following indications:1. Foraminal stenosis;2. Spinal stenosis;3. Degenerative Disc Disease;2. Spondylolisthesis; 4. Trauma;5. Pseudarthrosis;6. Instability of motion segments;

CONTRAINDICATIONSContraindications include but are not limited to the following aspects:(1) Prior fusion;(2) Laminectomy and/or any procedure with posterior bone structure removal; (3) Vertebral trauma with endplate collapse; (4) Any spondylolisthesis greater than level II;(5) Articular facet degeneration requiring bone removal; (6) Risk of infection or infection in progress, fever or inflammation; (4) Obesity;(8) Pregnancy;(9) Mental illnesses;

(10) Allergy to the system components;(11) Any anatomical, medical or surgical condition that might interfere with the procedure and preclude potential or intended benefits of the spinal implants;(12) Critical bone, joint or ligament conditions such as (but not limited to): Osteopenia, bone absorption, osteomalacia; Osteoporosis is a severe contraindication and shall be evaluated thoroughly before surgery; (13) Size and shape of the implant or its anchoring might be inappropriate for the required clinical results;(14) Use components from implants from other manufacturers or fixing systems;(15) Potential risk of unexpected breakage or anatomical damage to the patient, interference resulting in neurological, functional or any other potential deficit;(16) Unwillingness of the patient to follow the after surgery instructions; (14) Any other contraindication not described above.

POTENTIAL ADVERSE EFFECTSPotential adverse events that may occur after spinal surgery with or without instruments include, but are not limited to:(1) Detachment, bending and/or breakage of one or all the components of the system;(2) Any migration of the components of the system;(3) Pressure on the skin applied by the components of the implant on patient with inadequate tissue;(4) Damage to tissue or nerve derived from a wrong placement of the implant or use of the instruments;(5) Spinal liquid leak, deformities or damage;(6) Neurological and/or physiological disfunctions such as paresthesia, paralysis, hyperestesia or all the other adverse effects related to surgery and anaesthesia;(7) Infections;(8) Loss of urinary function;(9) Permanent or temporary sexual dysfunctions;(10) Variation of the curvature of the body, changes of the physiological range of movement following surgery;(11) Pseudorthrosis or delayed fusion or no fusion at all;(12) Bone loss, excessive growth or any other bone malformation;(13) Limitation or impossibility to temporarily or permanently perform daily tasks;(14) Mental behaviour change;(15) Permanent, temporary or future respiratory issues;(15) Permanent, temporary or future cardiovascular dysfunctions or alterations;(17) Death.Several surgeries may be required in order to solve or change potential adverse events.WARNINGSThe effectiveness and safety of the interspinous fusion device is only applicable to certain conditions with appropriate indications. The device may be supportive for mechanical instability like deformity, fractures, listhesis, dislocation, tumor, pseudoarthrosis. Its effectiveness and safety for any other condition are unknown.

!PRECAUTIONSThe Interspinous Dynamic Fusion System (IDF) is a device complementary to the interbody fusion cages. Therefore the spinal decompression system shall not be considered as the only spinal support. The interspinous and/or interbody cages shall be implanted exclusively by experienced surgeons with specific training in the use of Dynamic Fusion System (IDF). Therefore the interspinous system should not be considered as the only spinal support. No implant can withstand the loads deriving from the body without bone support. Taking into account the above, bending, breaking, loosening or disassembling may occur over time. Taking into account the above, bending, breaking, loosening or disassembling may occur over time. A successful result may not be achievable. Factors such as proper preoperative and operative procedures, comprehensive knowledge of the surgical techniques, accurate selection of the implant size and type are paramount for a successful treatment procedure. Patients with obesity, smokers, alcohol abuse are at risk of non-fusion after surgery. Patients in weak muscle or bone conditions or nervous system dysfunctions are poor candidates for spinal fusion as well. Prior, during or after surgery in order to evaluate or check the position of the implants, patient’s anatomy or any other adjustment, X-ray or CT or any other invasive diagnostic examination may be required.Proper, individual implant selection in terms of type, size, shape or design is vital to successful surgery. Proper implant and instrument handling is crucial. Extensive bending should be avoided. Sharp edges, reversed bending, scratching or notching may generate internal stress, which may weaken the implant or construct.IMPORTANT All required information regarding surgery, potential risks, benefits and adverse effects should be conveyed to the patient prior to surgery.PREOPERATIVE(1) Exclusively patients meeting the criteria described in the indications should be selected.(2) Patient conditions should be verified prior surgery. Any required diagnostics should be performed.(1) Efficient and adequate implant and instrument inventory must be verified and be available during surgery.(4) All implants, instruments and any other component shall be cleaned and sterilised before use. Sterility and expiry date of any implant, instrument or component delivered as sterile must be checked prior surgery.(5) Implants and instruments shall be stored in adequate conditions to guarantee sterility and protection from any contaminant or corrosive environment.(6) It’s highly recommended that all personnel interacting with any mechanical component of the spinal system should be familiar with all the components before using them.

INTRAOPERATIVE(1) Extreme caution shall be taken when performing surgeries in the spinal cord and nerve roots areas.(2) Whenever possible or required, an intraoperative diagnostic system should be used to facilitate surgery.(3) Breaking, bending, scratching, slippage, part loosening or improper use of any implant or instrument during surgery may result in injury to the personnel or patient.(4) The surgical techniques shall be strictly followed. Proper application of any instrument or implant may facilitate surgery.

(5) Before stitching the soft tissue make sure to double check all the implant positioning, geometrical relations, fixing, tightening or mounting operations for all screws, nuts or other fixing parts should be performed. Image diagnostics is highly recommended at this stage.

POSTOPERATIVEThe surgeon’s postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely important.(1) Detailed instructions on the use and limitations of the device should be given to the patient.(1) The patient should be warned to avoid falls or sudden jolts to the spine.(3) The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport. The patient should be advised not to smoke tobacco or utilise nicotine products, or to consume alcohol or non-steroidals or anti-inflammatory medications such as aspirin during the bone graft healing process.(4) As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic antibiotics may be considered, especially for high-risk patients.(5) Any retrieved device shall not be reused in another surgical procedure. As with all orthopaedic implants, the Interspinous Dynamic Fusion System (IDF) components should never be reused under any circumstances.

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Tsunami Medical S.r.l.Via XXV Aprile, 22

41037 Mirandola (MO)Italy

Design & QualityUNI EN ISO 13485:2016 Tel. +39 0535 38397

Fax. +39 0535 38399www.tsunamimedical.it

Rev.02 del 01/01/2019