B.Braun Aesculap Spine S4 Mode D'emploi/Description Technique page 3

The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
■
In cases of delayed or incomplete fusion, the implant may break or loosen as a result of excessive strains.
■
The life span of the implant depends on the patient's body weight.
■
Implant components must not be subject to extreme load arising from sports activities or strenuous physical
work.
■
Corrective surgery may be necessitated by implant loosening, fracture, or loss of correction.
■
Smokers present an increased risk of bone fusion failure.
■
The patient must undergo regular medical follow-up examinations of the implant components.
■
The patient must be advised that being overweight places such excessive pressure on the implant that the pros-
pect of failure becomes likely.
■
The patient must be advised that strenuous physical activity in the form of heavy lifting, excessive muscle strain,
exaggerated twisting, repeated bending and bending over or running should be avoided until the bones have
healed fully.
■
The patient must be instructed to keep pressure off the implant post surgery in order to prevent the onset of
clinical problems associated with implant failure.
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The implantation of the S Spinal System rod connectors requires the following steps:
4
►
Select the appropriate S Spinal System variant and anchoring implants according to the individual indication,
preoperative planning and bone situation found intraoperatively.
►
To prevent internal stresses and weakening of the implants, avoid scoring or scratching any components.
►
Position the rod connector on the rod at the site planned by the surgeon using the provided insertion/holding
instrument.
►
Do not unscrew the locking screws from the rod connector construct.
►
Do not assemble the locking screws with the other rod connector components.
►
Do not implant the rod connector if any locking screws are missing.
If the locking screws were removed or if they are missing, the rod connector can-
not be used!
►
In this case, choose a different rod connector for implantation.
CAUTION
►
Before tightening up the locking screws, ensure that the rod connector is positioned correctly.
►
For tightening and loosening the locking screws, always use the screwdriver and countering instrument intended
for this purpose.
►
Always tighten the locking screws with the 4 Nm torque wrench FW207R intended for this purpose.
Risk of injury if the locking screws are not fixed sufficiently!
►
Make certain that there is no patient tissue caught in the rod connector con-
struct.
►
Position the rod connector correctly.
WARNING
►
Ensure that the rods have been completely inserted into the rod connector.
►
Always tighten the locking screws with the 4 Nm torque wrench FW207R
intended for this purpose.
Risk of danger if the locking screws are tightened too firmly or not firmly enough!
►
Always tighten up the locking screws with the defined torque of exactly 4 Nm.
WARNING
Inadequate fixation due to incorrect rod position!
►
Always position the rod connector in such a way that the rod is completely
inserted into the rod connector.
►
Always position rods in such a way that the hexagon or the tip is located out-
WARNING
side the clamping area of the rod connector.
If patient tissue is caught in the rod connector, there is insufficient fixing!
►
Make certain that there is no patient tissue caught in the rod connector con-
struct.
►
Remove patient tissue from the rod connector construct or select another rod
WARNING
connector for implantation.
►
When tightening or loosening, only subject the locking screws to axial pressure. Avoid exerting lateral forces
when tightening or loosening the locking screws.
If the screwdriver or torque wrench are used incorrectly, there is damage to the
hexagon socket in the locking screws.
►
Ensure that the tip of the hexagon of the screwdriver or torque wrench is posi-
tioned entirely within the hexagon socket of the locking screw when tighten-
WARNING
ing or loosening.
More information on Aesculap implant systems is available from B. Braun/Aesculap or from the corresponding
B. Braun/Aesculap office.
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging.
TA013579 2019-08 V6 Change No. 60104