ACP Anterior Cervical Plate System SURGICAL TECHNIQUE
ACP TABLE OF CONTENTS INTRODUCTION 4 INDICATIONS AND CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 6 IMPLANT DESCRIPTION 7 INSTRUMENTS 10 SURGICAL TECHNIQUE 13 IMPLANT REMOVAL 17 3
ACP INTRODUCTION PLATES Anti-migration system Large window for graft and anatomical landmark visualization 18 mm wide and 2.5 mm thin Titanium Alloy plate Variable screw angulation - Cephalad-Caudal Screw angulation ± 10 - Medial-Lateral Screw angulation ± 10 R= 28 mm Axial bend radius 10 10 10 10 SCREWS Screws A B C Standard Self-tapping Screw (A) Recovery Self-tapping Screw (B) Standard Self-drilling Screw (C) Diameters Standard screw 4 mm Recovery screw 4.5 mm Color coded for length identification 10mm 12mm 14mm 16mm 18mm Laser mark for diameter identification 4
INDICATIONS AND CONTRAINDICATIONS INDICATIONS The Sintea Plustek Anterior Cervical Plate System is indicated for use in the cervical spine (C3-C7) for the following conditions: Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Trauma (fracture or dislocation) Spinal stenosis Deformities or curvatures (scoliosis, kyphosis, lordosis) Tumor Pseudarthrosis Failed previous fusion CONTRAINDICATIONS The contraindications of Sintea Plustek Anterior Cervical Plate System are analogous to those of similar products currently available, and include, but are not limited to: Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Severe osteoporosis is a relative contraindication because it may result in implant subsidence and loss of fixation. Any condition that significantly affects the likelihood of fusion may be a relative contraindication (e.g. cancer, diabetes, osteomalacia, heavy smoker, morbid obesity) and the surgeon must evaluate the relative risks and benefits individually with each patient. Other relative contraindications may include mental illness, drug abuse, or alcoholism as these may cause the patient to be non-compliant with post-operative guidance (e.g. bracing and physical therapy). Prior fusion at the levels to be treated. Any condition not described in the indications for use. If the implant of the Sintea Plustek Anterior Cervical Plate System is considered the best solution for the patient, and if the patient presents one or more of the above contraindications, it is essential the patient be informed of the possible negative consequences that might hinder the success of the procedure. 5
ACP WARNINGS AND PRECAUTIONS WARNINGS The usage of dissimilar materials (e.g. titanium and stainless steel) is strictly prohibited. Appropriately sized Anterior Cervical Plates must be used corresponding to patient needs and dimensions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Following are specific warnings, precautions, and adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to spinal fixation devices. General surgical risks should be explained to the patient prior to surgery. 1. Patients with prior spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous surgery. 2. PATIENT SELECTION In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: a. A patient may have multiple pain generators due to advances degeneration of the spine (e.g. intervertebral disc, facets, or bony stenosis). These conditions may be present at the index level or adjacent levels. Careful review of the clinical record, including radiographic studies and applicable diagnostic tests, should be performed to make the appropriate diagnosis. Concomitant conditions may reduce the effectiveness of the surgery and this should be discussed with the patient. b. The patient s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the implant or subsidence. c. The patient s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting, or muscle strain, the resultant forces can cause failure of the implant or subsidence. d. Patients that are non-compliant with postoperative guidance may place too much stress on the implant in the early postoperative period and compromise the maturing fusion mass. e. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. f. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. PRECAUTIONS Based on fatigue testing results, when using the Anterior Cervical Plate System, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system. 1. THE IMPLANTATION OF SPINAL FIXATION DEVICES SHOULD BE PERFORMED ONLY BY EXPERIENCED SURGEONS WITH SPECIFIC TRAINING IN THE USE OF SUCH DEVICES. THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. 2. PROPER SIZING OF THE IMPLANTS IS IMPORTANT. The surgeon should use trials to determine the appropriate implant to use. 3. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted spinal fixation device should never be reimplanted. Even though the device may appear undamaged, it may have small defects and internal stress patterns that may lead to early breakage. 4. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. The operating surgeon should avoid any notching or scratching of the device during surgery. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. 5. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the body s response to the implant and how the fusion mass is expected to develop. A patient that is non-compliant with postoperative guidance is particularly at risk during the early postoperative period. 6
IMPLANTS PLATES 1 LEVEL Hole to Hole (mm) Max Interaxis (mm) Overall length (mm) 1 Level Plate Max Interaxis 12 ACP-01T512 12 12 20 1 Level Plate Max Interaxis 14 ACP-01T514 14 14 22 1 Level Plate Max Interaxis 16 ACP-01T516 16 16 24 1 Level Plate Max Interaxis 18 ACP-01T518 18 18 26 1 Level Plate Max Interaxis 20 ACP-01T520 20 20 28 1 Level Plate Max Interaxis 22 ACP-01T522 22 22 30 1 Level Plate Max Interaxis 24 ACP-01T524 24 24 32 1 Level Plate Max Interaxis 26 ACP-01T526 26 26 34 1 Level Plate Max Interaxis 28 ACP-01T528 28 28 36 1 Level Plate Max Interaxis 30 ACP-01T530 30 30 38 2 LEVEL 2 Level Plate Max Interaxis 26 ACP-02T513 13 26 34 2 Level Plate Max Interaxis 28 ACP-02T514 14 28 36 2 Level Plate Max Interaxis 30 ACP-02T515 15 30 38 2 Level Plate Max Interaxis 32 ACP-02T516 16 32 40 2 Level Plate Max Interaxis 34 ACP-02T517 17 34 42 2 Level Plate Max Interaxis 36 ACP-02T518 18 36 44 2 Level Plate Max Interaxis 38 ACP-02T519 19 38 46 2 Level Plate Max Interaxis 40 ACP-02T520 20 40 48 2 Level Plate Max Interaxis 42 ACP-02T521 21 42 50 2 Level Plate Max Interaxis 44 ACP-02T522 22 44 52 2 Level Plate Max Interaxis 46 ACP-02T523 23 46 54 2 Level Plate Max Interaxis 48 ACP-02T524 24 48 56 3 LEVEL 3 Level Plate Max Interaxis 45 ACP-03T515 15 45 53 3 Level Plate Max Interaxis 48 ACP-03T516 16 48 56 3 Level Plate Max Interaxis 51 ACP-03T517 17 51 59 3 Level Plate Max Interaxis 54 ACP-03T518 18 54 62 3 Level Plate Max Interaxis 57 ACP-03T519 19 57 65 3 Level Plate Max Interaxis 60 ACP-03T520 20 60 68 3 Level Plate Max Interaxis 63 ACP-03T521 21 63 71 3 Level Plate Max Interaxis 66 ACP-03T522 22 66 74 3 Level Plate Max Interaxis 69 ACP-03T523 23 69 77 3 Level Plate Max Interaxis 72 ACP-03T524 24 72 80 7
ACP IMPLANTS PLATES 4 LEVEL Hole to Hole (mm) Max Interaxis (mm) Overall length (mm) 4 Level Plate Max Interaxis 60 ACP-04T515 15 60 68 4 Level Plate Max Interaxis 64 ACP-04T516 16 64 72 4 Level Plate Max Interaxis 68 ACP-04T517 17 68 76 4 Level Plate Max Interaxis 72 ACP-04T518 18 72 80 4 Level Plate Max Interaxis 76 ACP-04T519 19 76 84 4 Level Plate Max Interaxis 80 ACP-04T520 20 80 88 4 Level Plate Max Interaxis 84 ACP-04T521 21 84 92 4 Level Plate Max Interaxis 88 ACP-04T522 22 88 96 4 Level Plate Max Interaxis 92 ACP-04T523 23 92 100 4 Level Plate Max Interaxis 96 ACP-04T524 24 96 104 4 Level Plate Max Interaxis 100 ACP-04T525 25 100 108 4 Level Plate Max Interaxis 104 ACP-04T526 26 104 112 8
IMPLANTS SCREWS L (mm) SELF-TAPPING SCREW DIAM. 4 mm Self-tapping Screw Diam. 4 mm length 10 mm ACP-10T510 10 Self-tapping Screw Diam. 4 mm length 12 mm ACP-10T512 12 Self-tapping Screw Diam. 4 mm length 14 mm ACP-10T514 14 Self-tapping Screw Diam. 4 mm length 16 mm ACP-10T516 16 Self-tapping Screw Diam. 4 mm length 18 mm ACP-10T518 18 SELF-TAPPING SCREW DIAM. 4.5 mm Self-tapping Screw Diam. 4.5 mm length 10 mm ACP-11T510 10 Self-tapping Screw Diam. 4.5 mm length 12 mm ACP-11T512 12 Self-tapping Screw Diam. 4.5 mm length 14 mm ACP-11T514 14 Self-tapping Screw Diam. 4.5 mm length 16 mm ACP-11T516 16 Self-tapping Screw Diam. 4.5 mm length 18 mm ACP-11T518 18 SELF-DRILLING SCREW DIAM. 4 mm Self-drilling Screw Diam. 4 mm length 10 mm ACP-20T510 10 Self-drilling Screw Diam. 4 mm length 12 mm ACP-20T512 12 Self-drilling Screw Diam. 4 mm length 14 mm ACP-20T514 14 Self-drilling Screw Diam. 4 mm length 16 mm ACP-20T516 16 Self-drilling Screw Diam. 4 mm length 18 mm ACP-20T518 18 9
ACP INSTRUMENTS ACP INSTRUMENT SET ACP-1200S IMPLANT HOLDER ACP-1300S TEMPORARY PIN ACP-1301S PIN HOLDER ACP-1400S SINGLE FIXED GUIDE FOR DRILLING ACP-1401S DOUBLE FIXED GUIDE FOR DRILLING 10
INSTRUMENTS ACP-1402S ORIENTABLE GUIDE FOR DRILLING ACP-1500S CORTICAL AWL ACP-1501S FIXED AWL ACP-1600S TAP ACP-1700S PROBE ACP-1800S SCREWDRIVER 11
ACP INSTRUMENTS ACP-1801S FIXED SCREWDRIVER ACP-1900S PLATE GAUGE ACP-2000S PLATE BENDER 12
SURGICAL TECHNIQUE FASE STEP 01 APPROACH The patient is placed on the operating table in a supine position. Using the standard surgical approach, expose the vertebral bodies to be fused. Prepare the fusion site as per the appropriate technique for the given indication. STEP 02 PLATE SIZE SELECTION According to the needed fusion levels and to the patient s anatomy, choose the most convenient plate, by using the Plate Gauge. As further confirmation, screw the plate holder into the central hole of the selected plate and check the fitting of the implant in the operative theatre. Instruments ACP-1900S ACP-1200S Plate Gauge Implant Holder 13
ACP SURGICAL TECHNIQUE STEP 03 PLATE BENDING Once the correct plate size has been chosen, determine plate alignment. The Plate Bender may be used to give the plate its correct lordotic curvature, in order to comply with the patient cervical anatomy. Instruments ACP-2000S Plate Bender STEP 04 TEMPORARY PIN FIXATION After the plate is placed in the appropriate position by means of the Implant Holder, temporary pins can be inserted into the extremity holes, in order to allow a temporary grabbing of the plate to the vertebral bodies and to facilitate the screws insertion without loosening the correct plate position. The pins are handled by means of the proper holder, which can easily and safely seize and set them in their adequate holes. Insert the first pin and fix it into the vertebral body. Repeat with the second pin. Instruments ACP-1200S ACP-1300S ACP-1301S Implant Holder Temporary Pin Pin Holder 14
SURGICAL TECHNIQUE STEP 05 HOLE PREPARATION OPTION 1 In situ cannulated guides must be used to ensure the correct trajectory for the screw. Apply the appropriate Guide on the plate. Single and double, fixed and orientable guides are available. Insert the Awl into the Guide and push down while simultaneously twisting the awl handle. Remove the awl. OPTION 2 A standard drill (2.5-3mm diameter) could be used to prepare the screws seats. Select a drill bit of appropriate length; the drilling depth has to match the length of the provided monocortical screws (10mm - 12mm - 14mm - 16mm - 18mm); Drilling direction (20 latero-medially and 20 caudo-cranially) is controlled by the in situ cannulated guides, that must be used to ensure the correct angle screw trajectory. Single and double, fixed and orientable guides are available. Apply the appropriate Guide on the plate. Insert the drill bit into the guide and drill to desired depth. Remove the drill. Alternatively, self-drilling screws could be used. Instruments ACP-1400S ACP-1401S ACP-1402S ACP-1500S ACP-1501S Single fixed guide for drilling Double fixed guide for drilling Orientable guide for drilling Cortical awl Fixed awl 15
ACP SURGICAL TECHNIQUE SURGICAL TECHNIQUE STEP 06 SCREW INSERTION STEP 06 SCREW INSERTION After having removed the guides, the screws can After be inserted having removed into their the guides, seats, the using screws thecan be inserted proper into screwdriver. their seats, using the proper screwdriver. Connect the the selected screw of of the the appropriate length to the appropriate Screwdriver length and advance to the Screwdriver the screw until and the head of the advance screw is the fully screw seated until in the the plate. head of the screw is fully seated in the plate. Instruments ACP-1800S ACP-2100S Instruments ACP-1800S Optional Instruments ACP-1801S ACP-16XXS Screwdriver Universal Handle Screwdriver Fixed screwdriver Tap 4 mm Length XX ACP-1700S Optional Instruments Probe ACP-1600S NOTES ACP-1700S Tap Probe Thanks to the design of the screw head, the antimigration system, characterized by a NOTES deformable washer, lock the screw into the plate. Thanks to the design of the screw head, the antimigration system, characterized by a deformable washer, locks the The screw recovery into the screw plate. may be used as an emergency screw where the standard screw The has recovery stripped screw may the be bone used and as an a emergency larger screw screw where thread the standard is required. screw has stripped the bone and a larger screw thread is required. Repeat Repeat the the same procedure for for the the remaining screws. remaining Finally, remove screws. the temporary pins using the proper pin holder. Finally, remove the temporary pins using the proper pin holder. ACP 16 16
IMPLANT REMOVAL FASE STEP 01 REMOVE SCREW In case of implant revision or removal procedure, it is possible to remove the plate simply by unscrewing all the screws that fix the plate to the vertebra. For screw removal the Screwdriver must be used. Insert the Screwdriver in the screw head and tighten to thread the threaded tip of the inner shaft. Turn the instrument counterclockwise to extract the screw. Instruments ACP-1800S ACP-1801S Screwdriver Fixed screwdriver STEP 02 REMOVE PLATE After all the screws have been removed, the plate can then be removed. 17
ACP NOTES 18
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SURGICAL TECHNIQUE ACP USA Rev 01 del 22/10/2012 Sintea Plustek S.r.l. Commercial, administrative and registered office: Via E. Fermi 44 20090 Assago (MI) Italy Ph. +39 02 45 79 02 31 Fax +39 02 45 79 02 66 E-mail: info@sinteaplustek.com VAT NO. 04874470968 - Fully paid up capital 100.000,00 National Business Register: Milan (Italy) no. 1778805 Manufacturing Plant: Via Aquileia 33/H 20021 Baranzate (MI) Italy Ph. +39 02 45 79 02 31 Fax +39 02 45 79 02 66 E-mail: info@sinteaplustek.com Sintea Plustek LLC 407 Lincoln Rd. Suite 10/L 33139 Miami Beach (FL) USA Ph. +1 305 67 36 226 Fax +1 305 67 33 312 E-mail: info@sinteaplustek.com SISTEMA DI GESTIONE CERTIFICATO UNI EN ISO 9001 UNI EN ISO 13485 www.sinteaplustek.com