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

Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
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Selection of the implant components and their dimensions
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Positioning of the implant components in the bone
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Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
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All requisite implant components are ready to hand.
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Operating conditions are highly aseptic.
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All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
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The operating surgeon and operating room team are thoroughly familiar with the operating technique and with
the available range of implants and instruments; information materials on these subjects must be complete and
ready to hand.
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The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
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The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
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In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads.
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The life-span of the implant depends on the patient's body weight.
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The implant components must not be overloaded by extreme strains, hard physical labor or sports.
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Corrective surgery may be necessitated by implant loosening, fracture or loss of correction.
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Smokers present an increased risk of bone fusion failure.
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The patient must undergo medical check-ups of the implant components at regular intervals.
The following steps need to be carried out in order to implant the S
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Select the appropriate S Occipital Cervical Thoracic System variant and anchoring implants according to indi-
cation, preoperative planning, and intraoperative bone situation.
► 4
When selecting S Occipital Cervical Thoracic System screw types, make certain to select the correct diameter,
length, and canal orientation.
Incorrect application can result in trauma to the spinal cord and nerve roots!
►
Align and screw in the instruments, the pedicle screw and the polyaxial screw
only under X-ray control or using a navigation system.
WARNING
►
To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant compo-
nents.
►
Do not bend metal implants, except for the rods and cross connectors of the S
tem.
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Do not bend back, or bend excessively, the rods and cross connectors.
► 4
Only use bending instruments from the S Occipital Cervical Thoracic System instrument set for bending the rods
and cross connectors.
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For positioning the clamping screw, always use the clamping screw insertion instrument intended for this pur-
pose.
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For tightening and loosening the clamping screw, always use the screwdriver and countering instrument provided
for this purpose.
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Always tighten the set screws with the torque wrench intended for this purpose.
Risk of injury due to improper mounting of the set screw!
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Set the set screw in place correctly.
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Make certain that the rods are correctly positioned on the floor of the groove.
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Fully tighten the set screw, using the torque wrench.
WARNING
Correction loss due to insufficient fixation of the polyaxial head!
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Never loosen the connection of the polyaxial head again, once it has been
tightened.
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Tighten the set screw only after every necessary corrective measure has been
WARNING
performed.
Risk of damage to the implant due to overtightening of the set screw!
►
Always tighten the set screw to the exact torque specified for this purpose.
WARNING
Screw head expansion caused by tightening of the clamping screw without using
the countering instrument!
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Always use the countering instrument when tightening the set screw.
WARNING
Damage to the implant caused by applying the reduction instruments too high at
the implant!
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Always apply reduction instruments (e.g. distraction and compression forceps)
below the rod at the implant.
WARNING
Expansion of the implant head caused by derotation without derotation sleeves!
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Always use derotation sleeves for rod derotation.
WARNING
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When using a connector (hook, cross connector and other connectors) use special S
System mounting instruments.
Risk of loosening if occiput screw is incorrectly inserted!
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Ensure that the occiput screw is screwed in vertically into the plate.
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Ensure that the head of the occiput screw engages in the plate.
WARNING
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Always tighten the locking screws of the cross connector, clamp, hook and occiput plate with the torque wrench
and countering instrument for cross connectors intended for this purpose.
Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
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Occipital Cervical Thoracic System implant:
4
Occipital Cervical Thoracic Sys-
4
Occipital Cervical Thoracic
Disposal
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Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Implant Systems LLC
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA-Nr. 011796 2017-12 V6 Änd.-Nr. 57595