| Instructions for Titanium bone plates |
The introductions must be read carefully before clinical use |
| >>BRIEF INTRODUCTION |
| Titanium bone plates are elaborately made of well biocompatible and tough unalloy medical titanium and are applied with the corresponding titanium bone screws. The plates are the internal fixation materials of choice for bone reconstruction and fixation in oral-maxillo-facial surgery and neurosurgery. The products have ZI, YY, YL, YX, YT and YV types. |
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| >>MATERIAL |
| Unalloy titanium，ISO5832-2 |
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| >>INDICATIONS |
Titanium bone plates are implantable devices for reconstruction and internal fixation of bones in the oral surgery 、cranio-maxillofacial surgery and neurosurgery including: |
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1. Fractures.
2. Osteotomies, including orthognathic surgery .
3. Genioplasty.
4. Reconstructive surgery.
5. Revision surgery where other treatments or devices have failed. |
| POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS |
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1.Inflammation.
2.Inferior alveolar nerve injury.
3. Affect the bone growth.
4.Poor bone formation, Osteolysis, Osteoporosis, Osteomyelitis, inhibited, revascutarization, or infection can cause loosening, bending, cracking or fracture of the plates.
5. Migration, bending, fracture or loosening of the plates.
6. Nonunion, delayed union，or malunion, which may lead to breakage of the plates.
7. Metal sensitivity, or allergic reaction to foreign bodies.
8. Decrease in bone density because of stress shielding.
9. Discomfort, pain, abnormal sensation, or palpability due to the presence of the plates.
10. Increased fibrous tissue response around the fracture region and/or the plates.
11. Necrosis of bone.
12. Inadequate healing. |
Apart from these adverse effects there are always possible complications of any surgery such as, but not limited to, infection, nerve damage, and pain that may not be related to the plates. |
| >>WARNINGS |
Titanium bone plates aid the surgeon in the alignment and stabilization of the oral,cranio-maxillofacial skeletal bone for fixation of fractures, osteotomies and reconstructive surgery. While the plates are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the unsupported stress placed upon the plates by full load bearing. The plates with the screws are internal splints, or load sharing devices that align the fracture until normal healing appears. If there is delayed union, nonunion, or incomplete healing of bone, the plates can be expected to fail. So, it is very important that immobilization of the fracture region be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The size, the shape of bones and the soft tissue place limitation on the size and strength of the plates. Metal surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient’s activity level, and adherence to load bearing instructions have an effect on the service life of the implant. So, the surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the plates, but also must be aware of the mechanical and metallurgical aspects of metal surgical implants.
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1. Unalloy titanium, the materials of the plates are subject to corrosion. Implanting metals and alloys subjects them to constant changing environments of salts, acids, and alkalis that can cause corrosion. Putting dissimilar metals and alloys in contact with each can accelerate the corrosion process that may enhance fracture of the plates.
2. Correct handing of the plates is very important .The plates should be modified only when necessary. Modifications or excessive contouring of the plates may weaken the plates and lead to breakage. Notches or scratches put on the plates during the course of surgery may lead to breakage.
3. The plates may be took out after the fracture has healed. The plates can loosen, fracture, corrode, migrate, or cause pain. If the plates remains implanted after complete healing, the plates may cause stress shielding, which may increase the risk of second fracture in an active patient. The surgeon should weigh the risks versus benefits when deciding whether to take out the plates. Adequate postoperative management to avoid second fracture should follow the plates removal.
4. Intraoperative fracture of titanium bone screws can occur if excessive force (torque) is applied while seating titanium bone screws.
5. Adequately instruct the patient. It is very importance of the postoperative care. The patient’s ability and willingness to follow instruction is one of the most important aspects of successful fracture management. Patients with senility, mental illness, alcoholism, or drug abuse may be at higher risk of the plates failure since these patients may ignore instructions and activity restrictions. The patient is to be instructed in the use of external supports and braces that are intended to immobilize the fracture site and limit load bearing. The patient is to be made fully aware and warned that the platese does not replace normal healthy bone, and that the plates can break bend or be damaged as a result of stress, activity, and load bearing. The patient is to be made aware and warned of general surgical risks, complications, possible adverse effects, and to follow the instructions of the treating physician. The patient is to be advised of the need for regular postoperative follow-up examination as the instructions of the treating physician. The patient is to be advised of the need for regular postoperative follow-up examination as long as the plates remains implanted.
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