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Instruction leaflet - Please read prior to use
ORTHOFIX
®
CONTOURS PHP
PROXIMAL HUMERAL PLATE SYSTEM
Manufacturer
ORTHOFIX SRL
name
via Delle Nazioni 9
37012 Bussolengo (VR) Italy
Tel. 0039 (0) 45 6719000
Fax 0039 (0) 45 6719380
Symbol
Attention, see instructions for use PQ PHP
Limitations
PRODUCTS LABELED FOR SINGLE-USE MUST NOT BE REUSED.
and restrictions
Repeated reprocessing has minimal effect on reusable instruments.
on reprocessing
End of life is normally determined by wear and damage due to use.
DESCRIPTION
The Orthofix Contours PHP consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main
locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve
further stabilization of the bone fragments.
These implants are not intended to replace normal healthy bone. Load-bearing and activity levels will dictate the longevity of the implant. The
patient should understand that stress on an implant can be produced without actual weight-bearing. In the absence of solid bony union, the
weight of the limb alone, muscular forces associated with moving a limb, or repeated stresses of apparent relatively small magnitude, can result
in failure of the implant. Therefore, the patient should follow the
post-operative instructions given by the surgeon.
The product is intended for professional use only. Surgeons who supervise the use of the product must have full awareness of orthopaedic
fixation procedures as well as adequate understanding of the philosophy of the product. Prior to surgery, surgeons should be familiar with the
devices, instruments and surgical procedure, including the application and removal. Detailed operative technique guidance is available on
request; please contact Orthofix or your local distributor.
INDICATIONS
The Orthofix Contours PHP Proximal Humeral Plate is intended for fractures, osteotomies and non unions of the proximal humerus, particularly
in osteopenic bone.
CONTRAINDICATIONS
The Orthofix Contours PHP is not designed or sold for any use except as indicated.
Use of the Orthofix Contours PHP is contraindicated in the following situations:
Summary of Contents for CONTOURS PHP
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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...
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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...
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