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Implants trauma Universal Forearm Locking Plates System

 Open the catalog to page 1

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, plate might break. All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or...

 Open the catalog to page 2

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Pre-operative planning P. 8 Indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Pre-operative patient preparation P. 10 Reduction P. 11 Placement of the screws P. 13 Postoperative treatment P. 13 Explantation 3. Information P. 15 Locking P. 15 Dotize® P. 16 Order list P. 18 Reconditioning Manual

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Preface The Universal Forearm Locking Plates System is an osteosynthesis system for various forearm shaft fractures. The special feature of this implant is the free choice of screw placement. The user is able to set any desired screw in any hole, either locking or non-locking screw (except oblong hole). The free choice of screw angulation (+/- 15°, see page 15) provides an advantage in fracture treatment, especially in the case of complex fractures.

 Open the catalog to page 5

Cortical Screw, Locking, D=3.5mm, SH Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Cancellous Screw, Locking, D=3.5mm, SH Spiral Drill, D=2.0mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Guide Wire, Steel, D=1.6mm, L=150mm, TR, w. thread

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Properties Properties of the material: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Multi-directional Locking • Low-profile design • Free choice of plate position (volar, dorsal, radial, ulnar) • Straight and curved version adapted to the forearm anatomy • Plate lengths: 6, 9, 11-hole • Plate strength straight: 3.0mm • Plate strength curved: 3.5mm Axial indentations on the rear side of the plate...

 Open the catalog to page 7

Pre-operative planning Indications, Contraindications & Time of operation Indications: • For treatment of fractures, osteotomies and degenerative transformations. Primary: radius, ulna; secondary: fibula • Pediatric humeral and tibia fractures Contraindications: • The plates are not intended for shaft fractures of large bones such as humerus, femur and tibia (except pediatric humeral and tibia fractures) • Common situations that do not allow osteosynthesis • With advanced osteoporosis • In cases of skin and soft tissue problems that prevent a tension-free skin closure • Obesity • Lack of...

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Surgical Technique

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Pre-operative patient preparation • The patient is placed in the supine position with pneumatic deprivation of blood supply • The arm is positioned on a radiolucent surgical table Reduction • Temporary fixation of the plate using guide wires • Anatomical reduction of the fracture segments to the plate • Subsequent control under fluoroscopy Optionally, the plate can be stabilized using the ITS. Temporary Plate Holder (58164-15

 Open the catalog to page 10

Placement of the screws With the spiral drill, D=2.7mm, L=100mm, AO Connector (61273-100), drill through the drill guide, D=2.7/2.0mm (62202) into the distal compression hole. Determine appropriate length using the depth gauge, solid small fragment screws (59022). Insert the D=3.5mm cortical screw (32351XX) with the screwdriver, WS 2.5, selfholding sleeve (56252). Then, using the spiral drill, D=2.7mm, L=100mm, AO Connector (61273-100),drill through the drill guide, D=2.7/2.0mm (62202) into the proximal compression hole. Determine appropriate length using the depth gauge, solid small...

 Open the catalog to page 11

Using the spiral drill, D=2.7mm, L=100mm, AO Connector (61273-100) drill through the drill guide, D=2.7/2.0mm (62202) into the most distal plate hole. Determine appropriate length using the depth gauge, solid small fragment screws (59022). Insert the D=3.5mm cortical screw (32351XX) or the D=4.2mm locking cancellous screw (37422-XX-N) with the screwdriver, WS 2.5, self-holding sleeve (56252). The remaining plate holes are then filled, with either locking or non-locking screws. Subsequent control of plate position under fluoroscopy.

 Open the catalog to page 12

Postoperative treatment • Physical therapy immediately following surgery (no immobilization required) • In case of poor bone quality or insecure fixation, movement fixator for a maximum of 6 weeks • When a locking screw connection has been used, it is necessary to be aware that the diagnosis of a non-union may be very delayed. Explantation If desired by the patient, the implant can be removed Removal should be performed at the earliest 6 months - 1 1/2 years later or after radiographic verification of the healed bone. The problem of cold welding was resolved by using a special surface...

 Open the catalog to page 13

Locking Locking works because: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Type III anodization Dotize Type II anodization + Film becomes an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration Type - III - No visible cosmetic effect Dotize® Type - II Ti-Oxid Anodization Type II...

 Open the catalog to page 15

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