WRIGHT Salvation 153910-1, Руководство пользователя

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I. GENERAL PRODUCT INFORMATION
Through the advancement of surgical fusion hardware, the surgeon has been provided
a means of correcting deformity and reducing pain for many patients. While the implants
used are largely successful in attaining these goals, it must be recognized that they are
manufactured from metal, and that no implant can be expected to withstand the activity levels
and loads as would normal, healthy bone after fusion occurs.
Each patient must be evaluated by the surgeon to determine the risk/benefit relationship.
In using fusion implants, the surgeon should be aware of the following:
•
The correct selection and sizing of the implant is extremely important. Selection of
the proper size, shape, and design of the implant increases the potential for success. The
implants require careful seating and adequate bone support.
•
In selecting patients for surgery, the following factors can be critical to the
eventual success of the procedure:
1.
Patient’s occupation or activity. If the patient is involved in an occupation or activity
which includes substantial lifting or muscle strain, the resultant forces can cause
failure of the fixation, the device, or both. The implant will not restore function to the
level expected with normal healthy bone, and the patient should not have unrealistic
functional expectations.
2. Condition of senility, mental illness, or alcoholism. These conditions, among
others, may cause the patient to ignore certain necessary limitations and precautions
in the use of the implant, leading to failure or other complications.
3. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests
should be made prior to material selection or implantation.