| Instructions for Titanium bone screws |
The introductions must be read carefully before clinical use |
| >>BRIEF INTRODUCTION |
Titanium bone screws are elaborately made of well biocompatible and tough medical titanium alloy. The screws are the internal fixation materials of choice for bone reconstruction and fixation in oral-maxillo-facial surgery and neurosurgery. The screws have MA, MB, MC, and MD types. |
| |
| >>MATERIAL |
Ti 6Al 4V alloy， ISO5832-3 |
| |
| >>INDICATIONS |
Titanium bone screws are implantable devices for repair, reconstruction and internal fixation of bones in the oral surgery，cranio-maxillofacial surgery and neurosurgery including: |
|
1. Fractures.
2. Osteotomies, including orthognathic surgery.
3. Genioplasty.
4. Repair of skull defect.
5. Reconstructive surgery.
6. Revision surgery where other treatments or devices have failed. |
| POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS |
|
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 screws.
5. Nonunion, delayed union，or malunion, which may lead to breakage of the screws.
6. Migration, bending, fracture or loosening of the screws.
7. Metal sensitivity, or allergic reaction to foreign bodies.
8. Decrease in bone density due to stress shielding.
9. Pain, discomfort, abnormal sensation, or palpability due to the presence of the screwss.
10. Increased fibrous tissue response around the fracture site and/or the screws.
11. Necrosis of bone.
12. Inadequate healing. |
Apart from these adverse effects there are always possible complications of any surgical surgery such as, but not limited to, infection, nerve damage, and pain that may not be related to the screws. |
| >>WARNINGS |
Titanium bone screws 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 screws are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the unsupported stress placed upon the device by full load bearing. The screws with the plates are internal splints, or load sharing devices that align the fracture until normal healing occurs. If there is delayed union, nonunion, or incomplete healing of bone, the srews can be expected to fail. Therefore, it is important that immobilization of the fracture site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. The size and shape of bones and soft tissue place limitation on the size and strength of the screws. 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 screws. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the screws, but also must be aware of the mechanical and metallurgical aspects of the metal surgical implants.
|
|
1. Titanium alloy, the materials of the screws 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 screws.
2. Notches or scratches put on the screws during the course of surgery may contribute to breakage.
3. Intraoperative fracture of titanium bone screws can occur if excessive force (torque) is applied while seating titanium bone screws.
4.The screws may be taken out after fracture has healed. The screws can loosen, fracture, corrode, migrate, or cause pain. If the screw remains implanted after complete healing, the screws 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 screw. Adequate postoperative management to avoid second fracture should follow implant removal.
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 screws 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 screws does not replace normal healthy bone, and that the screws 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 screws remains implanted.
|
|
