1. Active infection at the site of surgery
2. General medical conditions including: impaired blood supply, pulmonary insufficiency (i.e. ARDS, fat embolism) or latent infection.
3. Patients who are unwilling or incapable of following post-operative care instructions.
4. Obese patients.
5. Suspected or documented metal allergy or intolerance.
WARNINGS AND PRECAUTIONS
1. All equipment should be carefully examined prior to use. Product integrity and performance are assured only if the packaging is
undamaged. DO NOT USE if packaging is compromised or if a component or instrument is believed to be faulty, damaged or suspect.
2. The Orthofix Contours PHP should not be used if the fracture is open or if the overlying skin is damaged.
3. Plates, screws, and hexagonal Fine Threaded Screws as well as certain parts of the instrumentation (where indicated on the label) are for
single-use only and must never be reused.
4. Smoking, chronic steroid use and the use of other anti-inflammatory drugs have been shown to affect bone healing and could potentially
have an adverse effect on bone repair during fracture healing.
5. Care should be used in the handling and storage of the components. The implants should not be scratched, notched or otherwise damaged
as these may reduce the functional strength of the component.
6. Fracture distraction for any time should be avoided during the operation, and fractures should never be locked in distraction, since this may
cause delayed union.
7. Bending of the hexagonal Fine Threaded Screws during insertion must be avoided, since this may lead to breakage of the implant. When
the chamfer is close to the plate, the speed of insertion must be reduced.
8. The selection of the main locking screw and hexagonal Fine Threaded Screws lengths are very important, they MUST NOT penetrate the articular
surface.
9. All implants and wires used in the humeral head, such as the central screws, the hexagonal fine threaded screws and the Kirschner wires
have to be positioned 5 - 10 mm from the second cortex.
10. If the thread of the hexagonal head of the Fine Threaded Screws is not in contact with the plate, the insertion of the hexagonal Fine
Threaded Screws should be completed manually or the hexagonal Fine Threaded Screws removed.
11. The Fine Threaded Screws should have a maximum angulation of +/-15° with respect to the plane of the plate in order to ensure good
purchase in their threaded hole.
12. It is recommended to apply the main locking screw, AT LEAST two hexagonal Fine Threaded Screws and AT LEAST two Diaphyseal Screws
for stabilization of the plate.
13. All implants, Kirschner wires and cannulated drill bits are all single-use devices and should NEVER be reused.
14. The Orthofix Contours PHP is available in a RIGHT and LEFT version, which are anatomically shaped. It is therefore important to select the
correct plate. DO NOT use a plate labelled “RIGHT” for a left humerus and vice versa.
15. As plates and screws are made of titanium, DO NOT use them in association with stainless steel implants, since they may cause an
electrolytic reaction. Wires for cerclage of the humeral head may be made of titanium or of a polymeric material.
16. Do not use components of the Orthofix Contours PHP in conjunction with products of other manufacturers, unless otherwise specified.
17. Wherever a Kirschner-wire is used to guide a screw or instrument into position, the following precautions should be taken:
A) The wire should always be NEW and should NEVER be reused.
B) The wire should be checked before insertion to exclude any scratches or bends in the wire; if any are found it should be discarded.
C) During the introduction of any instrument or implant over a wire, the surgeon should screen the wire tip as continuously as possible
to exclude inadvertently driving the wire further than intended.
D) During each pass of the instrument or implant, the surgeon should check that there is no bony or other debris built up on the wire
or inside the instrument or implant which might cause it to bind on the wire and push it forward.
18. Careful monitoring of the progress of healing must be undertaken in all patients. If callus is slow to develop, other measures may be
required to promote its formation, such as a bone graft, or exchanging the implant.
19. Any fixation device may break if subjected to the increased loading caused by delayed or non-union.
20. During treatment with the Orthofix Contours PHP the patient should not use crutches or other walking aids that could apply load on the
plate.
4
Summary of Contents for CONTOURS PHP
Page 2: ......
Page 106: ...Kirschner Orthofix Orthofix Orthofix Orthofix Orthofix 1 2 BHMA 1 70 30 2 106...
Page 107: ...4 132 C 270 F 132 C 270 F 15 4 30 30 3 1 FDA Orthofix Orthofix 30 Orthofix 107...
Page 108: ...Orthofix Orthofix 1 2 3 1 108...
Page 109: ...Orthofix 0 3 30 40 C 104 F I II III IV V VI VII VIII IX X XI 109...
Page 110: ...2 Orthofix 3 3 I II III 3 3 IV V VI VII VIII IX X I 110...
Page 111: ...II III Orthofix 0 5 80 C 176 F 80 IV V I II III IV V I II III IV V I II Orthofix 0 5 111...
Page 112: ...50 C 122 F 15 50 60 Hz III IV V 15 VI VII VIII IX X 3 4 5 112...
Page 113: ...Orthofix FDA Orthofix Orthofix 113 4 132 C 270 F 132 C 270 F 15 4 30 30...
Page 117: ...K 1 2 1 1 70 30 2 3 1 FDA 117...
Page 119: ...1 1 0 3 40 C 104 F 30 I II III IV V VI VII VIII IX X XI 119...
Page 120: ...2 3 3 I II III 3 3 IV V VI VII VIII IX X I II III 0 5 80 C 176 F 80 IV V 120...
Page 122: ...N A 4 132 C 270 F 132 C 270 F 15 4 30 30 5 FDA 122...
Page 127: ...1 Orthofix 0 3 40 C 104 F 30 I II III IV V VI VII VIII IX X XI 127...
Page 130: ...Orthofix 130...
Page 163: ...1 Orthofix 1 30 Orthofix 1 1 Orthofix 1 Orthofix 1 2 3 1 0 3 40 C 104 F 30 163...
Page 164: ...1 I II III IV V VI VII VIII IX X XI 2 3 3 1 I 164...
Page 167: ...Orthofix 167...
Page 168: ...168...
Page 169: ...169...
Page 170: ...170...
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Page 172: ...172...
Page 175: ...JP CN CS PL SL KR 175...
