B.Braun Aesculap Spine S4 Mode D'emploi page 2

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S Occipital Cervical Thoracic
Intended use
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The S Occipital Cervical Thoracic System implants are used for the dorsal,
monosegmental and multisegmental stabilization of occiptocervical bridges,
cervical and upper thoracic vertebrae.
System components
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The S Occipital Cervical Thoracic System is comprised of:
• Occiput plates
• Rods
• Mini polyaxial screws
• Set screw
• Hooks
• Transverse connectors
• Other connectors
The appropriate implant components from the S
can also be used.
A special instrument set is required to implant these components and to dis-
tract, compress and reposition cervical and upper thoracic vertebrae.
Materials
The materials used in the implant are listed on the package.
• Forged Titanium Alloy TiAl6V4 according to ASTM F136 or ISO 5832-3
• Pure Titanium according to ASTM F67 or ISO 5832-2
Indications
The purpose of implants performed intraoperatively is to support the normal
healing process. They are not intended for use either as replacements for nat-
ural body parts or to bear loads over the long term in the event the healing
process is incomplete or slow.
Use for the following indications:
• Degenerative instability
• Post-trauma instability
• Fractures
• Tumors
Contraindications
Do not apply in the presence of:
• Fever
• Acute or chronic vertebral infections of a local or systemic nature
• Pregnancy
• Acute osteopenia
• Medical or surgical conditions that could negatively impact the success
of the implantation
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
Side-effects and adverse interactions
Application of the system entails the following risks:
• Implantation failure due to:
– warping or bending
– loosening
– breakage
• Inadequately fixed implant
• Absence of, or delay in, fusion
• Infection
• Fractured vertebral body or bodies
• Trauma in
– nerve roots
– spinal column
– vessels
– organs
Safety information
General risk factors associated with surgical procedures are not described in
this documentation.
• The implant components were tested and approved for use in combina-
tion with Aesculap components. If other combinations are used, the
responsibility for such action lies with the operating surgeon.
• It is the operating surgeon's responsibility to ensure that implant compo-
nents are applied correctly during operative procedures.
• The operating surgeon must have a thorough command of both the
hands-on and conceptual aspects of the established operating tech-
niques.
• Assembling and implanting of the implant components is the respon-
sibility of the operating surgeon.
• Aesculap is not responsible for any complications arising from incorrect
diagnosis, choice of incorrect implant, incorrectly combined implant
components and/or operating techniques, the limitations of treatment
methods, or inadequate asepsis.
• The instructions for use of individual Aesculap implant components must
be followed.
• Under no circumstances may modular implant components from different
suppliers be combined.
• The implant components applied, along with their article numbers, the
name of the implant, as well as the batch number and serial number (if
available) must be documented in all patient records.
• During the postoperative phase, in addition to mobility and muscle train-
ing, it is of particular importance that the physician keeps the patient well
informed.
• Damage to load-bearing bone structures can result in loosening of the
components, bone or implant fractures, or other acute complications.
In order to detect any such problems as soon as possible, the condition of
the implant must be controlled at regular intervals postoperatively with
the aid of appropriate examination procedures.
• Delayed healing can cause implant components to fracture as a result of
metal fatigue.
• It is up to the attending physician to make any decisions with regards to
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removal of the S Occipital Cervical Thoracic System implant.
Sterility
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S Occipital Cervical Thoracic System implants are individually packaged. The
implants are supplied unsterile.
Store implant components in their original packaging. Remove them
from their original protective packaging only just prior to application.
Prior to use, preclean and steam sterilize implants in accordance with
applicable hospital guidelines for the preparation of sterile materials.
Use the implant system storage unit for sterilization and sterile prepa-
ration.
Never use either damaged implant components or implant components
that have been removed surgically.
The titanium implants are coated with a layer of oxide whose purpose is to
protect the metal. Their color may change slightly, but this has no bearing on
the quality of the implant.
Sterilize using steam sterilization, pay attention of the following:
The sterilization has to be done according to a validated steam steriliza-
tion procedure (e.g., in a sterilizer according to EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST46-1993 and validated according to
EN 554/ISO 13693). In case of application of the fractionated vacuum
procedure the sterilization has to be done using the 134 °C (274 °F)/
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SPINE System® (e.g., rods)
2 bar program with a minimal holding time of 5 minutes.
Application
The operating surgeon draws up an operation plan specifying and document-
ing the following:
• Implant components selected and their dimensions
• Position of the implant components in the bones
• Determination of intraoperative orientation points
The following conditions must be fulfilled prior to application:
• All requisite implant components must be ready to hand
• Operating conditions must be highly aseptic
• All the requisite implantation instruments, including specialized Aesculap
instruments for preparation of the implantation site, are present and in
good working order
• The operating surgeon and the operating room team must be familiar
with the particulars of the operating technique, the implant components
and implantation instruments, and this documentation must be available
on site
• All the requisite special instruments have been prepared for the implan-
tation of the various implant components, as well as for distraction, com-
pression, and repositioning of cervical vertebrae
• Those performing operations must be thoroughly conversant with the
rules governing medical practice, the current state of scientific knowl-
edge, and the contents of relevant articles by medical specialists from the
professional literature
• If the preoperative situation is unclear and an implant is already present
in the affected spinal region, information has been obtained from the
manufacturer
The operative procedure has been explained to the patient, and the latter's
understanding of the following information has been documented:
• Delayed healing or incomplete fusion can cause the implant to fracture
or loosen as a result of the extreme load to which it is subjected.
• The life-span of the implant is determined by body weight.
• Implant components must not be subject to extreme load arising from
sports activities or strenuous physical work.
• If the implant becomes loose, fractures or deviates from its correction
position, a revision operation must be performed.
• The patient must undergo a regular medical follow-up examination of
their implant components.
For implanting the S
ing steps need to be carried out:
Select the appropriate S
anchoring implants according to indication, preoperative planning and
bone situation found intraoperatively.
When choosing the S
make certain to select the correct diameter, length and canal orienta-
tion.
WARNING
To avoid internal stress on, and weakening of, the implant: avoid scoring
or scratching of the implant components.
Do not change the shape of any metal implants except for the rods,
transverse connector rods, and occiput plates of the S
Thoracic System.
Do not bend back, or bend excessively, the rods, transverse connector
rods, and occiput plates.
Always use bending instruments of the S
System instrument set for bending the rods, transverse connector rods,
and occiput plates.
For positioning the set screw, always use the set screw insertion instru-
ment intended for this purpose.
For tightening and loosing the set screw, always use the screwdriver and
countering instrument intendend for this purpose.
Always tighten the set screws with the torque wrench intended for this
purpose.
WARNING
WARNING
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Occipital Cervical Thoracic System implant, the follow-
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Occipital Cervical Thoracic System variant and
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Occipital Cervical Thoracic System screw types,
Trauma to the spinal columns and nerve roots due
to incorrect application!
Position instruments and insert pedicle and
polyaxial screw only with the aid of a radio-
graphic visualization or navigation system.
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Occipital Cervical
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Occipital Cervical Thoracic
Risk of injury due to improper mounting of the
set screw!
Set the set screw in place correctly!
Make certain that the rods are correctly
positioned on the floor of the groove!
Fully tighten the set screw, using the torque
wrench!
Correction loss due to insufficient fixation of the
polyaxial head!
Never loosen the connection of the polyaxial
head again, once it has been tightened.
Tighten the set screw only after every neces-
sary correction measure has been performed.
Damage to the implant caused by overtightening
of the set screw!
Always tighten the set screw with the exact
torque specified for this purpose.
WARNING
Screw head expansion caused by tightening of
the set screw without using the countering
instrument!
Always use the countering instrument when
tightening the set screw.
WARNING
Damage to the implant caused by applying the
repositioning instruments too high at the
implant!
Always apply repositioning instruments (e.g.
distraction and compression forceps) below
WARNING
the rod at the implant.
Screw head expansion caused by derotation with-
out using derotation sleeves!
Always use derotation sleeves for rod derota-
tion.
WARNING
When using a connector (hook, transverse connector and other connec-
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tor), use special S Occipital Cervical Thoracic System mounting instru-
ments.
Risk of screw back-out due to incorrectly inserted
occipital screw!
Make sure that the occipital screw is screwed
in perpendicularly to the plate.
Make sure that the occipital screw head
WARNING
snaps into place in the plate.
For tightening the locking screws of cross connector, clamp, hooks, other
connectors and occiput plate always use the torque wrench and coun-
tering instrument intended for this purpose.
Further information on B. Braun/Aesculap implant systems is readily avail-
able from B. Braun/Aesculap or from the B. Braun/Aesculap agency in your
region.
TA-Nr.: 011796 02/09 Änd.-Nr.: 32607