Osteomed MFx Mode D'emploi

Part No. 030-1567-ENG-FRN-ITL
Rev.M MFx
Mandibular Fracture/Reconstruction System
Product Information and Instructions for Use
Description
The O M MFx TM Rigid Fixation System is comprised of plates, screws and instrumentation used for fixation of maxillofacial and mandibular fractures and reconstructions. The
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system features 2.0mm and 2.4mm mandibular standard plates, locking plates, standard/locking plates, Angulated Locking plates, and reduction plates. The plates range in
thicknesses of 0.8mm to 2.5mm. The system also includes 2.0mm and 2.4mm diameter standard screws in lengths from 4mm to 22mm, 2.3mm and 2.7mm diameter standard safety
screws in lengths from 4mm to 22mm, 2.0mm diameter Auto-Drive ® screws in lengths from 4.0mm to 8.0mm, 2.0mm and 2.4mm diameter locking screws in lengths from 6.0mm to
18.0mm, 2.0mm and 2.4mm diameter Angulated Locking screws in lengths from 4mm to 22mm, 2.3mm and 2.7mm Angulated Locking safety screws in lengths from 4mm to 22mm,
2.0mm and 2.4mm diameter Angulated Locking Auto-Drive screws in lengths from 5mm to 8mm, 2.0mm Auto-Drive
®
diameter MMF screws in lengths from 10m to 20mm. The system instruments include drill bits, plate bending forceps, plate holding forceps, reduction forceps, plate cutters, cannulae,
taps, countersinks, plate bending pliers, plate cutters, drill guides and screwdrivers to facilitate the placement of screws and modification of plates.
Material
The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). The instrumentation is
made from various grades of stainless steel, anodized aluminum, and/or medical grade plastic.
Clinical Indications
The O M MFx TM Mandibular Fracture/ Reconstruction System is indicated for fracture fixation, mandibular reconstruction and surgery involving osteotomies and trauma.
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The O M Angulated Locking Fixation System is indicated for mandibular trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
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The O M 2.0 Locking Plate System is indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial
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deformities).
The O M MMF Screws are indicated for temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in
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conjunction with primary fixation devices.
The O M Reduction Plates and Forceps are intended for mandibular body fractures, symphysis fractures and parasymphysis for tension, compression or both.
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Rigid Fixation System implants, templates and drills are intended for single use only. System instruments are reusable. OsteoMed single use devices
The O M MFx TM
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cannot be reused and/or reprocessed. The product has been labeled as single use only for patient safety. The design of the device and the intricacies of the surfaces may not
facilitate cleaning and sterilization after contact with body tissues or fluids, so there is an increased risk of contamination if reused. This may lead to potential risks of cross
infection/contamination associated with using inadequately cleaned and sterilized devices. For cutting instruments the cutting efficacy may be reduced requiring the surgeon to use
increased force that might cause patient harm and/or increase the risk of thermal necrosis. Because these products have not been validated for multiple use, OsteoMed cannot
guarantee the safety and effectiveness of the device if it is used on more than one patient.
Contraindications
• Use of the O M MFx Rigid Fixation System is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously
TM
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sensitized to titanium; or in patients with certain metabolic diseases.
• It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation plate and screw implants and/or in patients
where there is insufficient bone or poor bone quality.
• The O M MMF Screws are also contraindicated in patients with disorders which could prevent the patient from following the limitations of temporary ligature and wire
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fixation.
• The use of 2.4mm Angulated Locking Auto-Drive ® screws are contraindicated in bi-cortical bone placement on the mandible.
Warnings
1. Manipulation of maxillofacial bones or tissues can potentially result in cardiac complications such as ectopic beats, atrioventricular block, bradycardia, syncope, vomiting, and
asystole. These are known complications during maxillofacial surgery and are not specifically related to any device.Plates and screws, wires, or other appliances of dissimilar
metals should not be used together in or near the implant site.
2. Use of an undersized plate or screw in areas of high functional stresses may lead to implant fracture and failure.
3. Plates and screws, wires, or other appliances of dissimilar metals should not be used together in or near the implant site.
4. Multiple bending may weaken the plate and could result in implant fracture and failure.
5. Use of screws in high density bone may lead to implant fracture or failure upon insertion.
6. It is recommended to remove any fractured implants from patients during surgery. If unable to remove, notify patient.
7. Use of excessive torque during insertion of screws may lead to implant failure.
8. O M MMF Screws: Use of an undersized wire or screw in areas of high abnormal functional stresses may lead to wire or screw fracture and failure.
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9. O M MMF Screws: Screws and wire are intended for temporary fixation and are to be implanted for a maximum of four weeks.
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10. Cannula is never to be used as a cheek retractor.
11. When placing additional screws, ensure that subsequent screw placement does not interfere with the other screws.
12. When using the reduction forceps (220-0231) with the reduction plates, do not use excessive force when lodging the tip into the slot.
13. When using the drill guide, do not apply a side load on the drill. This may result in friction, which may generate a thermal burn. Axial loading should always be used.
14. When using the transbuccal approach, ensure cheek retractor is used to protect soft tissue.
15. The 2.0mm 5 Hole Curved Reduction Plate (214-0110) slot is intended only for provisional fixation.
16. The 2.0mm 3 Hole Straight Plates (214-0231, 214-0111, 214-0112, and 214-0113) are all reduction plates.
17. Evaluation of the safety and compatibility of the device in the MR environment, the following concerns were determined based on the implant material, MDD 93/42/EEC and
ISO14630: magnetically induced displacement force and torque, radio frequency (RF) heating and image artifacts.
18. The O M MFx TM Rigid Fixation System has not been tested for safety and compatibility in the MR environment, nor has it been tested for heating or migration in the MR
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environment.
Maintaining Device Effectiveness
1. The surgeon should have specific training, experience, and thorough familiarity with the use of rigid fixation products and techniques.
2. The surgeon must exercise reasonable judgment when deciding which plate and screw type to use for specific indications.
The O M MFx
3. TM Rigid Fixation System plates and screws are not intended to endure excessive abnormal functional stresses.
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4. When loading a screw onto driver, apply a perpendicular force to engage screw cruciform with driver. The surgeon should avoid multiple insertions of driver into the same
screw to maintain self retention feature of screw and driver.
5. The O M MFx TM Rigid Fixation System is intended for temporary fixation only until osteogenesis occurs.
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6. All O M plates, screws, and instrumentation may be required for each surgery. Failure to use dedicated, unique OsteoMed instruments for every step of the implantation
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technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury. Failed devices may require re-operation
and removal. All implants are held in the organizer block. Remove lid from block by holding down the button, pull and lift lid to open.
7. Carefully inspect the O M implants prior to use. Inspect the instruments before and after each procedure to assure they are in proper operating condition. Instruments
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which are faulty, damaged, or suspect should not be used. They should be replaced or sent to O
8. When placing more than one screw, ensure that subsequent screw placement does not interfere with other screws. Insert the second screw on the opposite side of the
fracture or osteotomy site, and then all remaining screws, following the outlined procedures.
O M recommends the use of O M
9. products in a sterile environment.
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10. Drill using the appropriate pilot drill. Note: Speed and torque parameters must be in accordance to the Power System Instruction for Use. Use irrigation when pilot drilling.
NOTE: Drill Color Bands Denotes Size: 2.0mm drills are Blue and 2.4mm drills are Green.
11. After cutting plate, utilize diamond file on the plate cutter handle (220-0584) to remove sharp edges on the plate.
12. When using Plate Benders 220-0548 and 220-0529, note they can only be used with Reconstruction plates.
13. The legend for the Rainbow Drills is located on the back of the lid of the organizer blocks which contain Rainbow Drills. The six proximal color bands on the Rainbow Drills
denote the depth of the drilled hole: Red(0mm), Orange(4mm), Magenta(8mm), Black(12mm), Aqua(16mm) and Yellow(20mm).
14. The distal banding on the transbuccal instrumentation, including drills, denotes with which cannula the instrumentation is to be used.
15. Depth Gauge marking tolerance: ± 0.38mm
Instructions for Use, Auto-Drive Screws
®
The Auto-Drive screws are self drilling and can be inserted in one step. Insert the screw in a TaperLock screwdriver and drive into the bone at a 90° angle using moderate
®
pressure until the head is flush with the surface of the bone/plate. Higher torque may be required to fully engage the threads than when using a normal screw with a pilot drill.
NOTE: In high density bone pilot drilling may be necessary.
Instructions for Use, Locking Screw System
1. Expose and reduce fracture: After completing the preoperative plan, expose the fracture or osteotomy site. For trauma, reduce the fracture as required.
2. Select and prepare implants: Select the appropriate template/plate depending on the indication. For Reconstruction plates, allow for at least 3 screws per bone segment.
Orient the plate so the topside is facing out. Determine the appropriate screw type, locking or non-locking.
3. Place bending inserts into holes selected to receive screws. Contour the template to match the anatomy. An exact match is not required when using locking screws, as plate
stability is not dependent on plate-to-bone contact when screws are locked. Cut and contour plate to match template form. Plates can be cut with plate cutters.
4. Position the plate: Place the plate over the fracture or osteotomy site. Use the plate holding forceps to secure the plate to the bone, if desired.
5. Drill the first hole: Select the threaded drill guide and insert it into the first plate hole nearest the fracture or osteotomy site. Rotate the drill guide clockwise to engage the
threads in the plate. Drill using the appropriate drill bit.
6. Measure screw length: Remove guide and use depth gauge to measure hole depth to determine appropriate screw length.
7. Insert the screw: Insert the proper length locking or non-locking screw through the plate and tighten until secure.
8. Drill and place the remaining screws: Insert the second screw on the opposite side of the fracture or osteotomy site, and then all remaining screws, following the previously
outlined procedure. Securely tighten all screws unless resection is to follow.
9. For ablative procedures:
Resect the desired area
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Once the plate is in place, remove the plate and screws, taking note of each screw placement. Resect the desired area
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10. Replace the implants:
Place the plate back onto the osteotomy in its original position.
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Reinsert each predetermined screw.
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• Check all screws to ensure a secure fit in the plate.
11. Apply Bone graft if using 2.0 locking system: A vascularized bone graft must be applied to all 2.0mm constructs used in reconstructing the mandible.
Instructions for Use, Angulated Locking Screw System
1. Expose and reduce fracture: After completing the preoperative plan, expose the fracture or osteotomy site. For trauma, reduce the fracture as required.
2. Select and prepare implants: Select the appropriate template/plate depending on the indication. For Reconstruction plates, allow for at least 3 screws per bone segment.
Orient the plate so the topside is facing out. Determine the appropriate screw type, locking or non-locking.
3. Contour the template to match the anatomy. An exact match is not required when using angulated locking screws, as plate stability is not dependent on plate-to-bone contact
when screws are locked. Cut and contour plate to match template form. Plates can be cut with plate cutters.
4. Position the plate: Place the plate over the fracture or osteotomy site. Use the plate holding forceps to secure the plate to the bone, if desired.
5. Drill the first hole: Select the Angulated Locking Drill Guide and insert it into the first plate hole nearest the fracture or osteotomy site. Ensure Angulated Locking Drill Guide is
flush and perpendicular to the plate. Drill guide will provide up to 10 degrees of angulation in any direction. Drill using the appropriate drill bit.
NOTE: If transbuccal approach is needed, ensure that only the Neutral Drill Guide is used and drill the pilot hole utilizing the proper technique.
6. Measure screw length: Remove drill guide and use depth gauge to measure hole depth to determine appropriate screw length.
7. Insert the screw: Insert the proper length Angulated Locking or standard(non-locking) screw through the plate and tighten until secure.
8. Drill and place the remaining screws: Insert the second screw on the opposite side of the fracture or osteotomy site, and then all remaining screws, following the previously
outlined procedure. Securely tighten all screws unless resection is to follow.
NOTE: When placing additional screws, ensure that subsequent screw placement does not interfere with the other screws.
9. For ablative procedures:
Resect the desired area
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Once the plate is in place, remove the plate and screws, taking note of each screw placement. Resect the desired area
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10. Replace the implants:
Place the plate back onto the osteotomy in its original position.
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Reinsert each predetermined screw.
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Check all screws to ensure a secure fit in the plate.
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Instructions for Use, Mandible Lag Screw System
1. Select proper fracture access and reduce fracture with reduction clamp.
2. Place sliding length gauge over lag screw depth gauge cannula.
3. Determine drill placement area and angulations. Final drill path/angle is shown by tip of sliding length gauge.
4. Align open irrigation tip of cannula ventral to fracture sight to allow irrigation. Drill using drill bit.
5. Screw hole length can be determined by reading measurement on gauge or cannula. Cannula gauge is measured by reading mark on cannula where back of sliding length
gauge rests on cannula. Measurement can also be read by determining point of sliding length gauge that aligns with tip of cannula.
6. Countersink and/or tap if desired then place screw.
7. Retrieve the chosen screw with the appropriate driver stem and insert lag screw.
8. Drive the screw to compress the fracture.
Instructions for Use, Reduction Plates & Forceps:
1. Expose the fracture
3. Select the corresponding template
4. Drill forceps insertion holes
• Place the template across the fracture; ensure that the fracture lines fall entirely within the limit lines on the template.
• Drill the first insertion hole through the template's web hole and the second hole through one of the lateral holes.
Note: The etched lines present on the template indicate the maximum fracture displacement that can be reduced using this technique. If the fracture spans past the limit
lines, conventional reduction methods must be used.
Note: The lateral hole will align with the screw hole on the plate and serve as a pilot hole during screw placement. The other hole will fall within the slot on the plate.
Note: The holes will be drilled with the pilot drill corresponding to the screws used with the plate.
Note: Ensure that the template does not move location during the drilling of the holes and that the holes are drilled as close to parallel as possible.
5. Remove the template
Technique Tip: If little or no contouring of the plate is required go to Step 6, if significant contouring is required continue to Step 5.1
O M
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Rigid Fixation System
TM
MMF screws in lengths of 8mm, 11mm, and 14mm, and 2.4mm
®
M for disposition and repair.
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2. Select the appropriate plate
5.1. Reduce the fracture
Insert the forceps into the pre-drilled holes on the fragments and reduce the fracture.
5.2. Contour the template by placing above or below the forceps
Note: Plate must be flush with the bone to provide adequate contouring
5.3. Contour the plate to match the template.
Technique Tip: Utilize one of the OsteoMed plate contouring options.
Note: Multiple bending of the plate may weaken the plate and could result in implant fracture and failure.
5.4. Remove the forceps from the bone
6. Insert the forceps' tips into the plate until there is enough engagement between the tip of the forceps and the slot of the plate to adequately retain the plate.
6.1 One tip of the forceps must be placed in the slot and the second tip must be placed in one of the screw holes on the opposing side of the fracture.
Note: Do not use excessive force when lodging the tip into the slot
7. Engage the reduction forceps into the mandible fracture fragments, reduce the fracture.
Note: Forceps will continue to provide reduction/compression during screw placement.
8. Push the plate flush with the bone and drill the first screw hole using the appropriate drill.
9. Use Depth Gauge to measure the screw length required.
10. Insert the required screw and drive until fully seated.
11. Place opposite side lateral screw to maintain reduction.
12. Remove forceps and place remaining screws.
13. Close per standard practice.
For Further information on instruments or techniques, refer to O
1559
Instructions for Use, MMF Screws
1. Screws are placed through the mucosa without making an incision, taking care to avoid the roots of the teeth. Choose screw sites away from the root apices usually medial or
distal to the cuspid tooth.
2. Prepare bone with a pilot drill that is longer than the intended screw when using 2.4mm MMF screws, taking care to avoid critical structures.
NOTE: 2.0mm MMF Screws are self drilling, Auto-Drive .
®
3. Select appropriate MMF screw length.
4. Engage driver tip lightly into screw cruciform and apply moderate pressure. Vertically retract driver and screw from organizer and verify length with length gauge. Insert the
screw into the pilot hole and drive the screw to the appropriate depth, leaving the wire-passing hole exposed. Do not over torque or bottom out the screw.
5. For secondary screw ensure placement in the mandible is 5mm inferior and medial or lateral to the canine tooth roots.
6. A minimum of three pairs of MMF screws are recommended to ensure adequate stability. A pair consists of one screw in the mandible and an opposing screw in the maxilla.
7. Wire screws using 24 gauge stainless steel wire (207-0120) through exposed wire passing holes into maxillary and opposing mandibular MMF screw heads in a vertical and
"X" pattern. Tighten only enough to provide provisional fixation.
8. Establish occlusion and tighten wire fully.
Cleaning
• Products must be carefully cleaned prior to sterilization. Trained personnel must perform cleaning and mechanical inspection prior to sterilization.
Compliance is required with the equipment manufacturer's user instructions (manual and/or machine cleaning, ultrasound treatment, etc.) and recommendations for chemical
•
detergents.
O M recommends the following cleaning and sterilization instructions for Instrumentation:
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1. Clean all instruments thoroughly using mild detergent, soft brush and warm water. Ensure that dried blood, bone chips and other deposits are removed from the
instruments and sterilization tray.
2. Thoroughly rinse all instruments and the sterilization tray with water.
3. Arrange all the instruments in the sterilization case and ensure that the lid is in place and properly closed.
4. Steam Autoclave per the following Sterilization Instructions.
Sterility
Product is supplied NON-STERILE unless expressly labeled as STERILE.
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Select plates and screws are available sterile packaged (Gamma Sterilized) in 5-packs. DO NOT USE IF STERILE PACKAGE IS DAMAGED. DO NOT USE AFTER
•
EXPIRATION DATE.
OsteoForm Mesh is also available sterile packaged (Gamma Sterilized). DO NOT USE IF STERILE PACKAGE IS DAMAGED. DO NOT USE AFTER EXPIRATION DATE.
•
• Use of the sterilizer shall comply with the manufacturer's user instructions for sterilizers.
• The user facility must clean and disinfect devices prior to sterilization per standard hospital procedures.
Non-sterile devices are sterilizable by steam sterilization (autoclaving). For sterilization of O
•
Pre-Vacuum MFx Rigid Fixation Systems - Plastic Tray
TM
Steam Sterilization
Temperature: 273°F (134°C)
Time: 30 minutes
Dry Time: 55 minutes
Configuration: Wrapped tray
Wrapping Wrapped tray in two layers of 1-ply polypropylene wrap (Kimguard KC600
Technique: – 510(k) K082554).
Do not exceed 275°F (135°C), to avoid compromising functions of polymeric instrumentation.
Note: Biological indicator of G. stearothermophilus was used in sterilization validation.
Storage
Sterile packaged implants should be stored at controlled room temperature out of direct sunlight. Product package should be inspected prior to use for signs of damage or tampering.
Caution
Federal (United States) law restricts this device for sale by or on the order of a medical practitioner licensed to do so.
•
Do not attempt a surgical procedure with faulty, damaged, or suspect OsteoMed instruments or implants. Inspect all components preoperatively to assure utility.
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Alternate fixation methods should be available intraoperatively.
European Representative:
Cyton Biosciences LTD.
O M
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68 Macrae Road
3885 Arapaho Road
Eden Office Park
Addison, Texas 75001 USA
Ham Green
Customer Service: 800/456-7779
BRISTOL
Outside USA: 972/677-4600
BS20 0DD, U.K.
Tel: +44 (0) 117 973 9036
Single Use Only
Batch Code
(Lot Number)
Keep dry
Federal Law (U.S.A)
Restricts this device to sale by
or on the order of a physician.
Authorized Representative in
the European Community
Réf. n° 030-1567-ENG-FRN-ITL
Rév.M
Système de fixation rigide MFx
Système Mandibulaire pour Fracture/Reconstruction
Informations Produit et Mode d'Emploi
Description
Le S MFx TM d'Osteomed est constitué de plaques, vis et instruments servant à la fixation des fractures maxillo-faciales et mandibulaires ainsi que celles de
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reconstructions. Le système présente des plaques mandibulaires standard de 2,0 mm et 2,4 mm; les plaques standard-de verrouillage, les plaques de verrouillage à angles et les
plaques de réduction. L'épaissseur des plaques varie entre 0,8mm à 2,5mm. Le système comprend aussi deux vis de diamètre standard 2,0mm et 2,4mm dont la longueur varie
entre 4mm et 22mm, 2,3mm; des vis de sécurité de diamètre standard 2,7mm dont la longueur varie de 4mm à 22mm; des vis Auto-Drive
varie de 4,0mm à 8,0mm; des vis de verrouillage de diamètre 2,0mm et 2,4mm, dont la longueur varie de 6,0mm à 18,0mm; des vis de verrouillage angulaires de diamètre 2,0mm et
2,4mm dont la longueur varie de 4mm à 22mm; des vis de verrouillage de sécurité angulaires de diamètre 2,3mm et 2,7mm dont la longueur varie de 4mm à 22mm; des vis de
verrouillage Auto-Drive angulaires de 2,0mm et 2,4mm de diamètre dont la longueur varie entre 5mm et 8mm; des vis MMF Auto-Drive
®
8mm, 11mm, et 14mm et des vis MMF de diamètre 2,4mm dont les longueurs varient entre 10mm et 20mm. Les instruments du système comprennent des trépans, des pinces à
courber pour plaques, des pinces porte-plaques plaques, des pinces coupantes pour plaques, des pinces de réduction, des pinces coupe-plaques, dessondes, des tarauds, des
guide-trépan et des tournevis pour faciliter le placement des vis et la modification des plaques.
Matériau
Les vis sont en Alliage de Titane (ASTM F-136). Les plaques sont en Alliage de Titane (ASTM F-136) ou en Titane pur d'utilisation commerciale (ASTM F-67). L'instrumentation est
en acier inoxydable de différentes qualités, en aluminium anodisé, et/ou en plastique de qualité médicale.
Informations cliniques
Le S /
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chirurgie qui implique l'ostéotomie et le traumatisme.
Le S d'Osteomed est indiqué pour la reconstruction du traumatisme mandibulaire et pour la reconstruction orthognatique.
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Les OsteoMed 2.0 sont indiqués pour la chirurgie orale et maxillo-faciale, le traumatisme, la chirurgie reconstructive et la chirurgie
SYSTÈMES DE PLAQUES DE VERROUILLAGE
orthognatique (correction chirurgicale des déformations dento-faciales).
Les MMF OsteoMed sont indiquées pour la ligature temporaire et la fixation par verrouillage au fer en vue de la constriction temporaire et la stabilisation des segments d'os
VIS
fracturés dans la cavité orale, en rapport avec les dispositifs de fixation primaire.
Les OsteoMed sont destinées aux fractures mandibulaires, aux fractures symphysaires et para-symphysaires, pour la tension, la compression ou
PLAQUES ET PINCES DE RÉDUCTION
ces deux options.
Les implants du S MFx TM d'Osteomed, les modèles et les mèches sont destinés àusage unique. Les instruments du système sont réutilisables. Les
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appareils OsteoMed à usage unique ne doivent être ni réutilisés et/ou re-traités. Le produit a été labellisé à usage unique pour la sécurité du patient. L'aspect du dispositif et la
complexité des surfaces peuvent ne pas faciliter le nettoyage et la stérilisation après avoir été en contact avec les tissus ou les fluides corporels, donc il existe un risque plus accru de
contamination en cas de réutilisation. Ceci peut être une source potentielle de risques d'infection/contamination associée à l'utilisation de dispositifs nettoyés et stérilisés de manière
inadéquate. L'efficacité des instruments tranchants peut être réduite demandant au chirurgien de forcer davantage ce qui peut provoquer une douleur du patient et/ou accroître le
risque de nécrose thermique. Parce que ces produits n'ont pas été homologués pour un usage multiple, OsteoMed ne peut pas garantir la sécurité et l'efficacité du dispositif s'il est
utilisé sur plus d'un patient.
Contrindications
• L'utilisation du S MFx TM d'Osteomed est contre-indiqué dans les cas d'infections actives ou suspectées, ou chez des patients immuno-déficients; chez
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des patients ayant des antécédents d'allergie au titane ainsi que chez des patients souffrant des troubles métaboliques.
M MFx TM Surgical Technique Guide 030-1623 or OsteoMed Rigid Fixation Instrumentation 030-
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M implant systems, the following parameters should be used.
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MFx Rigid Fixation Systems -Aluminum Tray
TM
270°F (132°C)
10 minutes
55 minutes
Wrapped tray
Wrapped tray in two layers of 1-ply polypropylene wrap (Kimguard KC600
– 510(k) K082554) with towel placed between the wraps and bottom of
the tray.
Symbols and Definitions
Catalogue Number Date of Manufacture
( MFG Date)
Consult Instructions for Use Manufacturer (MFR)
Use by Do not use if sterile package is
(Date)
damaged
OSTEOMED August 2014
Attention, Sterile, Method of Sterilization Using
See Instructions for Use Irradiation
Caution, Consult
Accompanying Documents
O M
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TM
de 2,0mm de diamètre dont la longueur
®
de 2,0mm de diamètre en longueurs de
®
TMd'Osteomed est indiqué pour la fixation des fractures, la reconstitution mandibulaire et la
MFx
Printed in U.S.A.
Printed in U.S.A.
OSTEOMED August 2015