S4 Spinal System - Lumbar Deformity

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Aesculap S4® Spinal System - Lumbar/Deformity Legend Fig. 1 S4 monoaxial screws Fig. 2 S4 Element monoaxial screws Fig. 3 S4 polyaxial screws Fig. 4 S4 Element polyaxial screws

■ Limited physical ability ■ Persistence of symptoms that were to be treated by the implantation ■ Paresis ■ Subsequent surgery to remove the implant system ■ Metal/foreign body allergy or hypersensitivity ■ Dural tears ■ Meningitis

Safety notes The implant has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. Scanning a patient who has this implant may result in patient injury.

Intended use The S4 Spinal System-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar and thoracic spine. They comprise: ■ Mono/polyaxial screws ■ Rods ■ Hook ■ Cross connector ■ Rod connectors – parallel, axial and lateral offset ■ appropriate fixation elements Special instruments must be used for implanting these components, as well as for the distraction, compression and reduction of the lumbar and thoracic spine.

WARNING

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly. ■ General risk factors associated with surgical procedures are not described in this documentation. ■ The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques.

■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood vessels, muscles, and tendons.

■ The operating surgeon is responsible for combining and implanting the implant components, with or without bone cement.

■ Aesculap is not responsible for any complications arising from erroneous indication, wrong choice of implant, incorrect combination of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis.

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ASTM F136/ISO 5832-3 ■ ISOTAN®P pure titanium acc. to ASTM F67/ISO 5832-2 The titanium implants are coated with a colored oxide. Slight changes in coloration may occur, but do not affect the implant quality. ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.

Indications Surgically installed implants serve to support normal healing processes. They are not intended for use either as replacements for natural body parts or to bear loads over the long term in the event the healing process is incomplete or slow. Use for acute disorders of the spine that cannot be treated by other therapies: ■ Fractures ■ Pseudarthrosis or delayed healing ■ Dislocation ■ Degenerative instability ■ Post-discectomy syndrome ■ Spondylolisthesis ■ Kyphosis ■ Scoliosis ■ Stenosis ■ Post-trauma instability ■ Tumors ■ Osteoporosis (with the simultaneous use of bone cement and fenestrated screws) Risk of screw breakage caused by pedicle screws used for spondylolisthesis! ► Support the stabilization measure with an intercorporal fusion (ALIF, PLIF or TLIF). WARNING

Absolute contraindications Do not use in the presence of: ■ Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, Paget’s disease, bone tumors etc. ■ Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system ■ Suspected allergy or sensitivity to the implant materials ■ Acute or chronic vertebral infections of a local or systemic nature ■ Poor patient compliance or limited ability to follow medical instructions, particularly in the post-op phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity ■ Cases not listed under indications

Relative contraindications In the following circumstances, use of the implant system could represent an increased clinical risk and therefore requires precise, individual assessment by the surgeon: ■ Medical or surgical conditions that could negatively impact the success of the implantation, including wound healing disorders ■ Conditions that could subject the spine and implants to excessive pressure, ■ for example, pregnancy, obesity, neuromuscular diseases or disorders ■ Generally poor condition of the patient; for example, drug or alcohol addiction

■ The instructions for use of the individual Aesculap implant components and instruments must be observed. ■ The implant components were tested and approved in combination with Aesculap components. If other combinations are used, the responsibility for such action lies with the operating surgeon.

■ Do not, under any circumstances, combine implant components from different manufacturers. ■ Do not, under any circumstances, use damaged or surgically excised components. ■ Implants that have been used before must not be reused. ■ Delayed healing can cause implant breakage due to metal fatigue. ■ The attending physician shall make any decision with regard to the removal of implant components that have been used,

■ Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migration, and other severe complications.

■ To ensure the earliest possible detection of such causes of dysfunction, the implant must be checked periodically, using appropriate techniques.

■ 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.

■ Postoperatively, individual patient information, as well as mobility and muscle training, is of particular importance.

Sterility

■ The implant components are supplied in an unsterile condition. ■ The implant components are packaged individually. ► Store implant components in their original packaging and remove from their original protective wrapping only

immediately prior to processing. ► Use a suitable tray for cleaning/disinfection. ► Ensure that the implant components in their implant system storage devices do not come into contact with each

other or with instruments. ► Ensure that the implant components are not damaged in any way.

Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the following validated reprocessing procedure: Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Validated reprocessing procedure

WARNING

Side effects and interactions The general risks of surgery are assumed known and are therefore not described in these instructions for use. Potential risks and clinical consequences associated with use of the implant system include, but are not limited to: ■ Implant failure resulting from excessive load – Warping or bending – Loosening – Breakage ■ Poor stabilization, requiring subsequent revision surgery or surgery to remove the implant system ■ Failed or delayed fusion ■ Infection ■ Fractured vertebral body or bodies ■ Tissue reaction to implant materials ■ Hematomas and wound healing disorders ■ Injuries to – Nerve roots – Spinal cord – Blood vessels – Organs ■ Changes of the normal spine lordosis ■ Neurological disorders, including impairment of the gastrointestinal, urological and/or reproductive system ■ Pain or indisposition ■ Bursitis ■ Decreased bone density due to load avoidance ■ Bone atrophy/fracture above or below the spine section provided for

WARNING

Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Handle the implants with new gloves only. ► Keep the implant system storage devices covered or closed. ► Process implant system storage devices separately from instrument trays. ► Clean implants must not be processed together with contaminated implants. ► Process the implant components individually and separately if no implant system storage devices are available, ensuring that the implant components are not damaged in the process. ► Do not reuse surgically contaminated implants! Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood.

Cleaning/Disinfection Validated cleaning and disinfecting procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Do not clean with brushes or

Chapter Manual cleaning/disinfection and sub-chapter:

■ SW790T

other abrasives that would damage the product surface.

■ To prevent internal stresses and weakening of the implants, avoid scoring or scratching any components.

■ Chapter Manual cleaning with immersion disinfection

Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Do not clean with brushes or

Chapter Manual cleaning/disinfection and sub-chapter:

other abrasives that would damage the product surface.

■ Chapter Manual cleaning with

■ To prevent internal stresses and

ultrasound and immersion disinfection

weakening of the implants, avoid scoring or scratching any components. Mechanical alkaline cleaning and thermal disinfection

■ Place the product in a tray that

Chapter Mechanical cleaning/disinfecting and sub-chapter:

is suitable for cleaning (avoiding rinsing blind spots).

■ SW790T

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection Manual cleaning with immersion disinfection

Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure. For implant components that are to be resterilized:

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Mechanical cleaning/disinfecting

IV

Final rinse

RT (cold)

1

-

FD-W

-

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

V

Drying

RT

-

-

-

-

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infecting procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Sterilization ► Validated sterilization process

– Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Application

Manual cleaning with ultrasound and immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infecting procedure.

Mechanical alkaline cleaning and thermal disinfecting

The operating surgeon shall devise an operation plan that specifies and accurately documents the following: ■ Selection of the implant components and their dimensions ■ Positioning of the implant components in the bone ■ Location of intraoperative landmarks The following conditions must be fulfilled prior to application: ■ All requisite implant components are ready to hand. ■ Operating conditions are highly aseptic. ■ All requisite implantation instruments must be available and in working order, including specialized Aesculap implantation systems. ■ The operating surgeon and operating room team are thoroughly conversant 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. ■ 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. ■ The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the area operated on. ■ Special instruments ready for implanting the implant components and for the distraction, compression and reduction of the lumbar and thoracic spine The surgical procedure and following information has been explained to the patient, and the patient's consent has been documented: ■ In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads. ■ The life-span of the implant depends on the patient’s body weight. ■ The implant components must not be overloaded by extreme strains, hard physical labor or sports. ■ 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 medical check-ups of the implant components at regular intervals. ■ The patient must be advised that being overweight places such excessive pressure on the implant that the prospect 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. Implantation of the S4 Spinal System implant requires the following steps: ► Select the appropriate S4 Spinal System variant and and anchoring implants according to the individual indication, preoperative planning and bone situation found intraoperatively. Inadequate fixation due to incorrect screw selection! ► Apply cannulated monoaxial screws when using FRI instruments. WARNING ► Apply cannulated monoaxial screws when using FRI instruments. ► When selecting S4 Spinal System screw types, make certain to select the correct diameter, length and canal ori-

entation. 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 implant the S4 Spinal System rod connector, proceed as follows: ► Place the rod connector on the rod at the site calculated by the operator with the aid of the connector insertion/fixing instrument intended for this purpose. ► Do not unscrew the locking screws from the rod connector. ► Do not exchange the locking screw with the other rod connector components. ► Do not use the rod connector if any locking screws are missing. Rod connector is unusable if locking screws are removed or not present! ► Use another 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 torque 4 Nm wrench FW207R intended for this purpose.

WARNING

Risk of injury if the locking screws are not fixed sufficiently! ► Make certain that there is no soft tissue caught in the rod connector. ► Position the rod connector correctly. ► Ensure that the rods have been completely inserted into the rod connector. ► Tighten up the locking screws with the 4 Nm torque wrench.

► To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant compo-

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 4 Nm.

nents. ► Do not bend metal implants, except for the rods and the occipital plates of S4 Spinal System. ► Make certain the insert is correctly positioned before placing the rod and after manipulating it. ► Adjust the curvature of the rod to the anatomical situation. ► Do not bend back, or bend excessively, the rods and cross connectors. ► Only use the bending instruments of the S4 Spinal System instrument set for bending the rods and occipital

WARNING

plates. ► To position the locking screw, always use the locking screw insertion instrument intended for this purpose. ► For tightening and loosening the locking screw, always use the screwdriver and countering instrument intended

for this purpose.

WARNING

► Always tighten the locking screws with the torque wrench intended for this purpose.

WARNING

Risk of injury due to improper mounting of the locking screw! ► Position the locking screw correctly. ► Make certain that the rods are correctly positioned on the floor of the groove. ► Fully tighten the locking screw with the torque wrench. ► Break off the flanks only after fully tightening the locking screw (not for S4

element).

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 end of the hexagon or tip of the hexagon is located outside the clamping area of the rod connector. If soft tissue is caught in the rod connector, there is insufficient fixing! ► Make certain that there is no soft tissue caught in the rod connector. ► Remove soft tissue from the rod connector or select another rod connector for implantation.

► Only load the locking screws axially when tightening or loosening. Avoiding exerting lateral forces whilst tight-

ening or loosening the locking screws.

WARNING

Correction loss due to insufficient fixation of the implant head! ► Never loosen the connection of the implant head after it has been tightened. ► Tighten the locking screw only after every necessary corrective measure has been performed.

Risk of damage to the implant due to overtightening of the locking screw! ► Tighten the locking screw only with the exact torque specified for this purpose. WARNING

WARNING

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 when tightening or loosening the locking screws is positioned entirely within the hexagon socket of the locking screws.

Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate B. Braun/Aesculap office.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

Expansion of the implant head caused by tightening of the locking screw without application of the countering instrument! ► Always use the countering instrument when tightening the locking screw. WARNING

WARNING

Damage to the implant caused by applying the reduction instruments too high at the implant! ► Always apply reduction instruments (e.g. distraction and compression forceps) below the rod at the implant.

Expansion of the implant head caused by derotation without derotation sleeves! ► Always use derotation sleeves for rod derotation. WARNING Risk of damage to the implant caused by spondylolisthesis repositioning via the locking screw! ► Always use the rod persuader for spondylolisthesis reposition. WARNING

WARNING

WARNING

Inadequate fixation due to incorrect positioning of insert! ► When placing the rod, make certain that the insert is correctly positioned. ► After manipulating the rod, make certain that the insert is correctly positioned. ► After final locking, check that the insert is correctly positioned. Inadequate fixation due to incorrect positioning of the rod in the screw head, see Fig.1-4! ► Adjust the curvature of the rod to the anatomical situation. ► Do not bend the rod in the region of the screw head. ► Make certain and check that the screw head is at right angles to the rod. ► Make certain and check that the rod is positioned securely in the groove base.

► Always use the appropriate flank breaking forceps for breaking off the flanks (not applicable for S4 element). ► If the screw head comes loose during revision of the larger polyaxial screws (∅ 7.5 mm or larger), remove the

remaining screw component with the SW 3.5 screwdriver. Inadequate fixation due to incorrect rod position! ► Always position rods with hexagon and tip in such a way that the hexagon and the tip is outside the implant head. WARNING ► For tightening the locking screws of the cross connector, always use the torque wrench and countering instru-

ment intended for this purpose.

TA011187

2019-09

V6

Change No. 60104