Technical Guideline. MONDE face. Technical and clinical information. OMF / Oral Maxillo Facial. Modular OMF-System Cluster

Transcription

1 Technical Guideline Technical and clinical information MONDE face Modular OMF-System Cluster 2000 OMF / Oral Maxillo Facial

2 Structure technical guideline Implants Screws Plates Mesh Instruments Screw-receiving and fixation Drilling Measuring Plate-receiving and positioning Bending, Outlining Cutting Bending, Outlining Cutting Containers Trays for: Implants Instruments MONDE face Table of contents Overview Page 3 Screws Page 4-5 IMF Screws Page 6-7 Plates - MICRO 1200 Page 8 - MINI 1700 Page 9 - MINI 2000 Page CAD Plates Page 15 Titanium MESH Page Instruments - for Screws Page for Plates Page for MESH Page 29 Containers Page Clinical Cases Page

3 Overview MICRO 1200 The titanium implant system for highest standards in the field of osteosynthesis in the upper third of the skull. Color code: blue 1200 MONDE face 1700 MINI 1700 The titanium implant system with smaller plates and screws as perfect complement to the osteosynthesis in the upper two thirds of the skull. Color code: green 2000 MINI 2000 The titanium implant system specifically designed for the osteosynthesis of the oral and maxillofacial surgery and universally usable. Color code: red Areas of Application Systems Naso-orbital area Infra-orbital area External wall of maxillary sinus Frontal sinus Fixation of bone grafts Cranial area Midface Le Fort I, II, III Mandible Orthognathic surgery 3

4 Implants Screws Features & Advantages Screw head-design self-retaining Safe self-retaining mechanism of screw and screwdriver blade Easy and simple removal of screw Different connection types: CF (CROSS-FIT) MCD (Mondeal Contour Drive) STANDARD (only 2.0 screws in the MINI 2000 system) Screw thread self-tapping Optimal self-tapping ability thanks to sharp and precise thread Stable fixation in the bone Atraumatic screw tip avoids impairments and irritations of the soft tissue Gently for patient Screw tip atraumatic Overview Screws MICRO 1200 MINI 1700 MINI 2000 Screw Ø (in mm) Self-retaining Screw (Lengths in mm) Emergency Screw (Lengths in mm) Self-drilling Screw (Lengths in mm) (3/4/5/6/7/9/11/13/15) Ø 1.5 (4/6/11/13/15) (3/4/5/6/7/8/9/11/13/15) Ø 2.0 (5/7/9) (4/5) (4/5/7/9/11/13/15/17/19) Ø 2.3 (5/7/9) (5/7) Length Ø Screw head: MCD CF Standard 4

5 Implants Screws Additional Features & Advantages of the S-DRIVE Screw Screw tip self-drilling Self-drilling screw for jaw bone, midface and skullcap No pre-drilling necessary Indications: fracture and orthognathic surgery, orbital area Contraindications: The use of the S-DRIVE screw may be restricted or contraindicated in use with compact cortical bone, for example, mandibular base and lower jaw angulation, as well as splintered fractures Note from General IFU Self-drilling screws are not recommended in very small, thin and loosened bone fragments because the fragments may be displaced by the axial pressure of insertion. S-DRIVE self-drilling Benefi ts of titanium for implants In general, pure titanium (DIN EN ISO /ASTM F67) is used for the manufacturing of bone plates while the titanium alloy (DIN EN ISO /ASTM F136) is used for the manufacturing of bone screws. Worldwide, these materials are used for short and long-term implants in the osteosynthesis for decades. For the following reasons: Completely biocompatible Corrosion-resistant Non-toxic in the biological environment Failure-free imaging with X-rays, computed tomography (CT) and magnetic resonance imaging (MRI) 5

6 Implants Screws IMF Quick Fix Features & Advantages Screw head-design self-retaining Safe self-retaining mechanism of screw and screwdriver blade Easy and simple removal of screw Different connection types: CF (CROSS-FIT) MCD (Mondeal Contour Drive) Screw thread self-tapping Optimal self-tapping ability thanks to sharp and precise thread Stable fixation in the bone Atraumatic screw tip avoids impairments and irritations of the soft tissue Gently for patient Screw tip atraumatic Screw tip self-drilling Self-drilling screw for jaw bone No pre-drilling necessary Ø Length Lengths in mm: 8/11/14 Ø in mm: 2.0 Two ways of wiring: Tightening the ligature wire through the pucture (waist) By passing the wire through the holes (2 cross holes) Note from General IFU Self-drilling screws are not recommended in very small, thin and loosened bone fragments because the fragments may be displaced by the axial pressure of insertion. 6

7 Implants Screws IMF Quick Fix Description Oral Maxillofacial procedures often require an intermaxillary fixation in order to create a safe and reliable occlusion. The IMF Quick-Fix Set guarantees fast and stitch-securely intermaxillary fixation in traumatology and dysgnathia surgery. Advantages: Infection protection for the operating surgeon Secure IMF even with reduced or non-existing dentition Periodontal and caries-preventive, particularly in long-term IMF Gentle and fast removal Permanent availability Saving of time Indications for the use Small depots of local anasthesia are set in the paranasal region of the vestibular fold and if necessary also on both sides of the zygomatic-alveolar crest, as well as at the corresponding place in the mandible (cave n. mentalis). Without previous incision, drilling is made through the mucoperiosteum with the 1.5 mm drill perpedicular to the bone. With the self-retaining screwdriver we place the MONDEAL IMF screws in the upper maxilla and in the mandible taking care that their heads stand slightly above the mucosa. Now the intermaxillary fixation (IMF) can be performed, regardless of the fact whether the patient is partially or totally toothless. Up to now neither infections nor irritations of the mucosa have occured during the clinical use. The biocompatibility of the MONDEAL Titanium IMF screws and their atraumatic head allow a short- as well as long-term IMF without problems. The removal of the screws happens easily and timesaving. Steel ligature wire 7

8 Implants Plates MICRO 1200 Fixation plates (Thickness 0.6 mm) for 1.2 -Screws 16-hole Plates straight without bar Plates straight with bar Orbital plates T-Plates without / with bar X-Plates without bar L-Plates without bar L-Plates with bar H-Plates Y-Plates without / with bar Indications Upper third of the skull Naso-orbital area Infra-orbital area External wall of maxillary sinus Frontal sinus For fine bone structures Bones without any compression and torsion Osteosynthesis for children 8

9 Implants Plates MINI 1700 Fixation plates (Thickness 0.6 mm) for 1.7 -Screws 24-hole 16-hole Plates straight without bar Plates straight with bar Orbital plates T-Plates without / with bar X-Plates without / with bar L-Plates without bar L-Plates with bar L-Plates with bar, 110 Y-Plates without / with bar Z-Plates with bar Indications Upper two thirds of the skull Naso-orbital area Infra-orbital area External wall of maxillary sinus Frontal sinus Bones with low compression and torsion Cranial Area Midface Le Fort I, II, III 9

10 Implants Plates MINI 2000 Fixation plates (Thickness 1.0 mm and 0.6 mm) for 2.0 -Screws 16-hole only 0.6 only 1.0 only 1.0 Plates straight without bar Plates straight with bar Orbital plates only 1.0 only 1.0 L-Plates without bar L-Plates with bar Indications Entire skull area Naso-orbital area Infra-orbital area External wall of maxillary sinus Frontal sinus Cranial area Midface Le Fort I, II, III Mandible Orthognathic surgery 10

11 Implants Plates MINI 2000 Fixation plates (Thickness 1.0 mm and 0.6 mm) for 2.0 -Screws only 1.0 only 1.0 only 0.6 L-Plates with bar, 110 T-Plates without / with bar H-Plate only 1.0 only 1.0 Y-Plates without / with bar Double Y-Plates without / with bar Double T-Plates without / with bar BLUE SERIES Plates (Thickness 0.8 mm) for 2.0 -Screws 16-hole Bone fractures and osteotomies in the midface region. Always to be applied if the 1.0 mm plates are too thick and the 0.6 mm low-profi le plates too thin and fl exible. Plates straight without / with bar L-Plates without bar L-Plates with bar,

12 Implants Plates MINI 2000 Special orthognathic plates; for 2.0 -Screws JALLUT Gliding Hole Miniplate Thickness: 1.0 mm 3 different bar lengths (8 / 10 / 12 mm) Application / Fixation: The gliding hole and the millimeter-marking of the bar allow an intraoperative fine adjustment of the plate and the lower jaw before the final fixation: Fixing of screw Then affix screw 3 in the sliding hole without tightening. Lower jaw fine-tune. Fixing screw 3 fixing screw 4. Indications: Mandibular fractures and orthognathic surgery (sagittal splitting) Clinical Case Fig. 1 Patient with performed Le Fort 1 / Sagittal Split osteotomies on both sides. Gliding hole plates located on the left and right side of the mandible. Fig Patient with dislocated lower jaw fractures. Gliding hole plate on the left upper oblique line of the mandible (Champy s ligne oblique ). 12

13 Implants Plates MINI 2000 Special orthognathic plates; for 2.0 -Screws BULL Chinplate Thickness: 1.0 mm 5 different bar lengths (4 / 6 / 8 / 10 / 12 mm) Clinical Case Preformed chin titanium plates for semi-rigid osteosynthesis with forward or reverse relocation of the chin. Slight adjustment of the chin plate to the bone contour. Developed in cooperation with Prof. Dr. Dr. H.G. Bull Krefeld, St. Josefshospital Special orthognathic plates; for 2.0 -Screws PAULUS Le Fort 1 Plate Thickness: 0.8 mm 6 different bar lengths (3 / 4 / 5 / 6 / 7 / 8 mm) This plate shapes were developed by Prof. Paulus, were modified in close cooperation with MONDEAL and adapted perfectly to the surgical indication. Indication: Le Fort 1 Osteotomies 110, right 110, left 13

14 Implants Plates MINI 2000 Mandibular Plates (Thickness 1.5 mm) for 2.0 -Screws CAD-Plattes rectangular CAD-Plattes rectangular, curved Plates straight with bar Plates straight without bar 10-hole 20-hole 30-hole 41-hole Indications Mandible Traumatology Mandibular fractures See also: MONDE mandible The modular Mandible System Cluster consisting of the three systems MPS, BMR and FRACTURE, has been especially designed for the reconstruction of the mandible, trauma applications and fractures. Thus, it covers the entire spectrum of all common indications for the lower jaw area. Trauma / Polytrauma Reconstruction of the mandible Tumor surgery Fractures of the mandible 14

15 Implants Plates CAD Plates MICRO 1200 (Thickness 0.6 mm) MINI 1700 (Thickness 0.6 mm) MINI 2000 (Thickness 1.0 mm) for Screw triangular 3-hole for Screw for Screw for Screw square 4-hole 6-hole 8-hole 4-hole 6-hole 8-hole 4-hole 6-hole 8-hole for Screw for Screw for Screw rectangular 4-hole 6-hole 8-hole 4-hole 6-hole 8-hole 4-hole 6-hole for Screw rectangular (strengthened bars) 8-hole 10-hole Areas of application Upper third of the skull Upper two thirds of the skull Entire skull area; especially mandible 3-hole 4-hole 6-hole 8-hole 4-hole 6-hole 8-hole 8-hole 10-hole CAD-Plate triangular CAD-Plates square CAD-Plates rectangular CAD-Plates rectangular (strengthened bars) MONDE face CAD-Plates for a stable three-dimensional osteosynthesis Indications Entire skull area Traumatology Orthognathic surgery Reconstructive surgery 15

16 Implants Titanium MESH Flexible MESH MICRO MESH Hexagonal MESH MONDE face Titanium MESH Highest stability For the reconstruction of large-scale bone defects and comminuted fractures in the maxillofacial and cranial area Indications Tumor resections Bone defects Pseudoarthrosis Osteomyelitis Trauma Neuro surgery 16

17 Implantate Titan MESH Titanium MESH MICRO 1200 MINI 1700 MINI 2000 for Screw for Screw MICRO MESH Thickness: 0.1 mm and 0.2 mm Thickness: 0.1 mm and 0.2 mm for Screw Flexible MESH Thickness: 0.6 mm for Screw for Screw Hexagonal MESH Thickness: 0.6 mm Thickness: 0.6 mm Areas of application Indications For stable coverage of bone defects in the upper skull and orbital area For stable coverage of small and larger bone defects in the upper skull and midface For stable coverage of small and larger bone defects in the upper skull, midface and mandible Clinical Cases Fig Repositioning of an open comminuted fractured anterior wall of the frontal sinus and osteosynthesis with Totanium MESH and screws. Fig. 3 Reconstrucion of the right mandible with Titanium MESH and autogeneous spongiosa following tumor resection and radiatic 17

18 Instruments for screws Screw-receiving and fixation System Screwdriver handle Blade Holding device Color code Types MICRO 1200 Blade, self-retaining MCD 1.2 Holding device * with blade, not self-retaining none CF MINI 1700 Blade, self-retaining MCD 1.7 CF Holding device * with blade, not self-retaining none MINI 2000 Blade, self-retaining MCD 2.0 CF Holding device * with blade, not self-retaining none STANDARD * Holding device, consisting of: Blade, not self-retaining Collet Sleeve 18

19 Instruments for screws Screw-receiving and fixation Screw-receiving out of the tray with self-retaining blade Insert screwdriver blade into the screw head and press firmly. Remove the screw vertically. Screw-receiving out of the tray with holding device (not self-retaining blade) Insert screwdriver blade into the screw. Then slide the sleeve of the holding device downwards so that the collet can encompass the screw head. Remove the screw vertically. Note from General IFU: Connection screwdriver and screw head It is essential to ensure that the screwdriver/screw head connection is aligned exactly in the vertical direction; otherwise, there is an increased risk of mechanical damage to the implant or the screwdriver. When engaging the bone screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head. This results in axial alignment and full contact between screwdriver and screw. 19

20 Instruments for screws Screw-receiving and fixation Assembly of blade (self-retaining) and screwdriver handle

21 Instruments for screws Screw-receiving and fixation Assembly of 3-piece holding device (no self-retaining blade) and screwdriver handle Components: Screwdriver handle Blade, not self-retaining Sleeve Collet 21

22 Instruments for screws Drilling Drill for screws Color code Diam. x Length Working length Connection MICRO x 46 mm 5 mm 1.0 x 48 mm 8 mm 1.0 x 50 mm 15 mm MINI x 46 mm 5 mm 1.4 x 48 mm 8 mm 1.4 x 50 mm 15 mm Stryker 1.5 x 46 mm 5 mm MINI x 48 mm 7 mm 1.5 x 50 mm 9 mm 1.5 x 50 mm 22 mm 1.5 x 105 mm 22 mm Length Diameter Ø Working length For angled handpieces: Drill for screws Color code Diam. x Length Working length Connection MINI x 18 mm 5 mm 1.5 x 23 mm 10 mm 1.5 x 28 mm 15 mm Dental 22

23 Instruments for screws Drilling Transbuccal trocar and drill guide, consisting of: 1 2 Handle Cheek retractor Drill guide Trocar There are 2 versions: - For self-retaining blades - For holding devices (no self-retaining blades) The transbuccal trocar and drill guide is used for an extraoral access when having tight spaces. Notes from General IFU: Drills Small Drills are recommended for single use only. Damage is difficult to detect due to the small dimensions. Drills are provided with depth stops to prevent accidental penetration beyond the targeted bone. A drilling speed of rpm must be maintained to avoid overheating and bone necrosis. When using high speed power sources, the user must verify with the manufacturer a setting that corresponds to a maximum speed of 800 rpm. When using twist drills, it is essential to provide adequate cooling by means of copious normal saline irrigation (NaCl) to minimize thermal damage to the bone tissue. The combination of cooling and low speed (<800 rpm) significantly contribute to the reduction of screw loosening due to bone de-mineralization. Twist drills are developed and indicated for work at low speeds (<800 rpm). Higher rates of rotations may result in failure of the drill and potential injury to the user, patient or third parties. Axial guidance of the drill considerably reduces the risk of breakage and wear. Always use the shortest drill possible given the clinical indication. Longer drills are naturally susceptible to more eccentric rotation, especially when operated in air, free of resistance. The user must verify the compatibility of the drill with the attachment hand piece. In addition, regular maintenance and inspection of the hand piece are essential to prevent damage to the drill. 23

24 Instruments for screws Measuring Depth measuring gauge (Measuring range 0-30 mm) for 1.2 -Screws Depth measuring gauge (Measuring range 0-50 mm) for 1.7 / 2.0 -Screws Notes from General IFU: Depth measuring gauges A depth gauge can be used to measure the depth of the hole drilled to determine the length of the bone screw to be inserted. If not otherwise expressly specified, the screw length is measured by the plate hole (i.e. applied plate). The value displayed on the scale of the depth gauge corresponds to the entire length of the bone screw. The length specified on the packaging label is the entire length of the bone screw. The screw measuring scale of the implant tray is laid out on the entire length. If the depth gauge has an angled probe on the end of the sensor, the surface facing the body of the instrument is the measuring point and not the surface facing away from the body. Factors such as profile height, screw seat in the hole of the bone plate, etc. have been taken into account in the depth gauges according to the product system. 24

25 Instruments for screws Measuring Screws measuring plate Screw diameter The scale on the left side measures the length of the screw if the screw is fixed on a holding device (with no self-retaining blade). The scale on the right side measures the length of the screw if the screw is fixed on a self-retaining blade. Holding device with blade, not self-retaining Blade, self-retaining The closed holding device has to be positioned laterally aligned in the fitting slot. For exact measurement, the screw has to be positioned with the screw head laterally aligned in the fitting slot. Notes from General IFU: Measuring plates Measuring plates and screw measuring scales in trays are only intended for rough determination of screws in length and diameter. For diameter drilling jigs on the measuring plates, the screw must be carefully positioned and pulled out again to avoid jamming or stripping of the screw. When used improperly, particles of material could be transferred from the gauge to the screw. 25

26 Instruments for plates Plate-receiving and positioning With the instruments for plate-receiving and positioning, the plates are removed from the implant tray and placed in position on the bone. MINI 2000 MINI 1700 MICRO 1200 Plate holding fork/ball Receiving Positioning Choose the respective plate holding device for the system. Hold the plate with the plate holding fork only at the bars (not at the plate holes). The plate holding ball serves to facilitate the positioning, holding and moving of the plate on the surface of the bone. 26

27 Instruments for plates Bending and outlining Vertical bending Horizontal bending Aderer modular plate bending pliers Notes from General IFU: Bending instruments Bone plates can be easily, quickly and precisely adjusted to any possible surface using bending instruments. The cold process during the bending procedure increases the hardness of the titanium and decreases its flexibility. Therefore, it is essential that the required form of the implant be achieved with as few bending maneuvers as possible. Excessive bending can cause the plate to break postoperatively. The convergence of extreme angles and small bending radii must be avoided due to the risk of damage to the implant (cracks, deformed screw holes, etc.) detectable postoperatively on a microscopic level. In these cases, the implant must be replaced by a new implant bent with greater care. Deformed screw holes mean not only an increased risk of breakage of the implant in this area, but also mean complications in the precision placement of the screw head. 27

28 Instruments for plates Cutting Plate cutter MICRO 1200 MINI 1700 Hint for crop mark Cutting line Pin for plate hole Place the plate with the hole on the pin of the plate cutter. The hint on the top shows on which side the cut takes place. The cutting edge should be always in the bar area between the holes using all the plate cutters available. MINI

29 Instruments for MESH convex MESH bending pliers Preforms concave The MESH bending pliers enables to shape all types of mesh in certain radii gently and precisely in a simple manner. You can choose between two preforms (M-preform and L-preform) with varying radii, which can be changed as needed. The use of the MESH bending pliers saves time and prevents buckling of the material during molding. MESH cutter Using the MESH cutter, the mesh can be cut to the desired size and shape. 29

30 Container Modular Container System The MONDE face modular design principle provides the user a variety of configuration options for an individual combination of screws, plates and instruments. This advantage is also reflected in the modular container system. The container components are arranged and combined depending on the user s preferences and the selection of the individual elements. 30

31 Container Trays with inlays for implants (screws and plates) and for small instruments (drills, blades etc.) Sterilisation container Basket for instruments 31

32 Frontal bone Os frontale Clinical case 1 Gender, Age: Female patient, 23 years Incident: Suffered from an impact with a glass bottle Diagnosis: Anterior frontal sinus wall fracture Treatment: By a coronal approach the open reduction of the anterior frontal sinus wall could be fixed with osteosynthesis material, plates and screws of 1.2 and Mesh. 32

33 Nasal bone Os nasale Clinical case 2 Gender, Age: Female patient, 49 years Incident: Suffered a facial trauma accident in the pedestrian traffic Diagnosis: Naso-orbital-ethmoid-fracture, type III Treatment: By a wound access, the reduction of the naso-orbital-ethmoid fracture could be fixed, with repositioning the extraoculare muscles and nasal fracture, ethmoid and the inner orbita with osteosynthesis material, plates and screws of 1.7 mm. 33

34 Cheek bone Os zygomaticum Clinical case 3 Gender, Age: Male patient, 20 years Incident: Suffered a facial trauma in a traffic accident as a motorcyclist Diagnosis: Lateral orbital wall fracture Treatment: By a wound access, the reduction of the fracture of the lateral orbital wall could be fixed with osteosynthesis material, plates and screws of 1.7 mm. 34

35 Cheek bone Os zygomaticum Clinical case 4 Gender, Age: Male patient, 52 years Incident: Suffered facial trauma in traffic accident as car driver Diagnosis: Lateral orbita wall fracture Treatment: By an access, type tube on the eyebrow, the reduction of the fracture of the lateral orbital wall could be fixed with osteosynthesis material, plates and screws of 1.2 mm. 35

36 Cheek bone Os zygomaticum Clinical case 5 Gender, Age: Male patient, 47 years Incident: Suffered facial trauma in a traffic accident as a car driver Diagnosis: Fracture of the cheekbone and lower edge of the orbita Treatment: By an infraorbital access, the reduction of the lower orbita could be fixed with osteosynthesis material, plates and screws of 1.2 mm. 36

37 Cheek bone Os zygomaticum Clinical case 6 Gender, Age: Male patient, 43 years Incident: Suffered facial trauma of assault with a sharp object (Machete) Diagnosis: cheek bone fracture Treatment: By access through the traumatic injury the reduction of the fracture of the cheekbone could be fixed with osteosynthesis material, plates and screws of 1.7 mm. 37

38 Upper jaw Maxilla Clinical case 7 Gender, Age: Male patient, 28 years Incident: Suffered facial trauma in a traffic accident as a motorcycle rider Diagnosis: fracture of upper jaw Treatment: By intraoral approach, the reduction of the malar fracture could be fixed with osteosynthesis material, plates and screws of 1.7 mm. Clinical case 8 Gender, Age: Male patient, 28 years Incident: Suffered facial trauma in a traffic accident as a motorcycle rider Diagnosis: maxillary type Le Fort II fracture Treatment: By intraoral approach, the reduction of the Le Fort I fracture was performed with osteosynthesis material, plates and screws of 1.7 mm. 38

39 Upper jaw Maxilla Clinical case 9 Gender, Age: Male patient, 52 years Incident: Suffered facial trauma in a traffic accident as a car driver Diagnosis: Maxillary fracture Le Fort I Treatment: By intraoral approach, malar fracture reduction was performed with osteosynthesis material, plates and screws of 1.7 mm. 39

40 Lower jaw Mandible Clinical case 10 Gender, Age: Male patient, 22 years Incident: Suffered facial trauma in traffic accident as a car driver Diagnosis: Mandibular fracture parasymphyseal Treatment: by intraoral approach jaw fracture reduction could be fixed using osteosynthesis material, plates and screws of 2.0 mm. 40

41 Lower jaw Mandible Clinical case 11 Gender, Age: Male patient, 25 years Incident: Suffered facial trauma by falling from high altitude Diagnosis: mandibular angle fracture Treatment: By intraoral approach, reduction of the jaw fracture could be performed with osteosynthesis material, plates and screws of 2.0 mm. Clinical case 12 Gender, Age: Male patient, 20 years Incident: Suffered facial trauma in a traffic accident as a car driver Diagnosis: Mandibular body fracture Treatment: By intraoral approach, a jaw fracture reduction could be performed by using osteosynthesis material with plates and screws 2.0 mm. 41

42 IMF Inter-Maxillary-Fixation Clinical case 13 Gender, Age: Female patient, 16 years Diagnosis: Strong myofunctional syndrome due to abnormal maxillary development with retrognathism of the upper maxilla and angle class III interlocking tooth position 1/2 pb right and left of the midline and upper bite of the front line of the upper maxilla. Treatment: Combined orthognathic/surgical therapy of the maxilla with advancement of the upper jaw after cephalometric model operation and rhinoplasty. Due to a largely already harmonized position of the teeth rows there was no need for brackets. Therefore it was performed an intraoperative intermaxillary fixation using the IMF-QUICK-FIX-Set to reach the ideal position before placing the MONDEAL miniplates. The pictures show the corresponding ligatures with the snare wires and 4 MONDEAL Titanium screws of the IMF-QUICK-FIX-Set in typical position on the upper maxilla and the mandible. There are also no signs of irritation of the mucosa, about 14 days postoperative. The screws were removed without any problem and there was no need to use local anaesthesia. 42

43 IMF Inter-Maxillary-Fixation Clinical case 14 Gender, Age: Male patient, 17 vears Diagnosis: triple mandible fracture (collum both sides and front left). The dislocated front fracture was treated with a MONDEAL CAD-plate. Due to the intracapsulator collum fracture on the right side and the collum fracture on the left side we had to make an intermaxillary fixation for 14 days. The IMF was performed using the QUICK-FIX-System. We chose in this case the QUICK-FIX-System instead of the usual technique using arch bars and wires due to the patients Hepatitis B infection and because there was a substantial gain of time intra-operatively. Clinical case 15 Gender, Age: Female patient, 74 years Diagnosis: After crashing on the mandible she had collum fractures on both sides (dislocated on the right, non-dislocated on the left side). There was no possibility to make an intermaxillary fixation by using arch bars and wires due to the very defective natural denture. Only the use of the IMF-QUICK-FIX-Set made it possible to perform a reliable and safe intermaxillary fixation as well intraoperatively during the 14 days period in which the jaws of the patient had to be kept immobilized. 43

44 High Quality Implants Made by MONDEAL We reserve the right to make catalog and design changes arising from further developments and modifications. Pictures, product descriptions and texts are the property of MONDEAL Medical Systems GmbH. Further use and reproduction by Third Parties requires written consent from MONDEAL Medical Systems GmbH. All rights reserved! Note: Responsibility for the selection of the patient, for adequate training as well as the decision as to the choice and use of the implants, a post-operative removal or retention of implants is the sole decision of the surgeon. All brands and logos referred to in this brochure, registered by Third Parties, are subject without restriction to the legal provisions currently in force and to the rights of ownership of the respective registered owner MONDEAL Medical Systems GmbH Am Gewerbering Mühlheim a. d. Donau/Germany Phone Fax mail@mondeal.de 97-T116-E MONDE-face 01/ 10-16