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| Instructions for Titanium mesh plates |
The introductions must be read carefully before clinical use |
| >>BRIEF INTRODUCTION |
Titanium mesh plates are elaborately made of well biocompatible and tough unalloy medical titanium and are applied with our corresponding titanium bone screws. Titanium mesh plate is an implant for cranial bone defect repair or cover. The mesh plates have WT and WP types. |
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| >>MATERIAL |
Unalloy titanium，ISO5832-2 |
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| >>INDICATIONS |
Titanium mesh plates are an implanted prosthetic device used to repair or cover a skull defect or hole in the neurosurgery. |
| POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS |
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1、Postoperative infection
2、Breakage of the mesh plates.
3、Migration or loosening as a result of titanium bone screws unfastens
4、Endermic accumulated-liquid after operation
5、Endermic infection
6、Metal sensitivity, or allergic reaction to a foreign body.
7、Dissatisfaction with the figuration of the repair surgery.
8、As a metal implants in human body forever, it may has some adverse effects, like electrolysis or foreign body stimulated reaction.
9、The mesh plates may deformation if external force imposed; And they can not return to a previous shape after deformation. |
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 implant. |
| >>WARNINGS |
Metal surgical implants such as titanium mesh plates and screws 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. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the mesh plates, but also must be aware of the mechanical and metallurgical aspects of the mesh plates.
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1.Unalloy titanium, the materials of the mesh 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 mesh plates.
2. Correct handing of the mesh plates is extremely important. The mesh plates should be modified only when necessary. Modifications or excessive contouring of the mesh plates may weaken the mesh plates and contribute to breakage. Notches or scratches put in the mesh plates 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. Adequately instruct the patient. Postoperative care is important. 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 device 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 device does not replace normal healthy bone, and that the device 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 device remains implanted. |
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