S4 Spinal System - Lumbar Deformity

en AESCULAP® S4® Spinal System Lumbar/Deformity Legend A B C D

S4 monoaxial screws S4 Element monoaxial screws S4 polyaxial screws S4 Element polyaxial screws

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply to all implant components of the S4® Spinal System that are supplied in unsterile condition. Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

Note The short summary of safety and clinical performance of the product is available in the European Database for Medical Products (EUDAMED).

2.1

Product description

Additional information on Aesculap implant systems is available from B. Braun/Aesculap or from your local B. Braun/Aesculap agency.

2.1.1

Materials

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

2.2

Areas of use and limitations of use

2.2.1

Intended use

The S4 Spinal System implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar and thoracic spine.

2.2.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. Use for severe disorders of the spine that cannot be treated by conservative therapies: ■ Fractures ■ Pseudarthrosis or delayed healing ■ Degenerative instability ■ Post-discectomy syndrome ■ Spondylolisthesis ■ Hyper-/hypokyphosis ■ Hyper-/hypolordosis ■ Scoliosis ■ Stenosis ■ Post-trauma instability ■ Tumors ■ Osteoporosis (with the simultaneous use of bone cement and fenestrated screws)

2.2.3

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, 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

2.2.4

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

2.3

Risks, adverse effects and interactions

As part of the legal duty to inform, the following typical risks, interactions and side effects associated with the use of surgical instruments are pointed out. 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 re/vision 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 ■ 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

2.4

Safety information

2.4.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Always follow the safety advice and information given in the instructions for use. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. Aesculap is not responsible for complications caused by: ■ incorrect indication or implant selection ■ incorrect surgical technique ■ incorrect combination of implant components ■ combination not approved by Aesculap with components from other manufacturers ■ exceeding the limitations of the treatment method or non-observance of essential medical precautions The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product. Special instruments must be used for implanting these components, as well as for the distraction, compression and reduction of the lumbar and thoracic spine.

2.4.2

Product-specific safety information

WARNING 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.

2.4.3

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.5

Patient education

Within the framework of the patient education, the relevant circumstances needed for consent must be explained to the patient in accordance with their level of understanding, pre-existing knowledge and need for information. This includes: ■ Diagnosis, procedure and risk clarification ■ Operative procedure ■ Advantages and disadvantages of the procedure ■ All alternative procedures that can be considered The patient must be properly informed about the procedure and in particular about the following information: ■ 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 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. ■ Postoperatively, individual patient information, as well as mobility and muscle training, is of particular importance. ■ 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.

2.6

Application

2.6.1

Documentation

The user 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 Important information concerning the implanted product and the operation can be noted down on the patient ID. The patient ID can be ordered separately from the manufacturer. Each package contains additional labels showing the designation, article and lot number and – if applicable – the individual serial number of the product. ► Use these labels for documentation in the patient’s file (for the hospital) and the patient ID (for the patient). The surgical procedure has been explained to the patient, and the patient’s consent has been documented. Note A printable version of the implant card, a patient information brochure and a guide on how to fill out the enclosed implant card (if applicable) are available online at www.bbraun.com/arthroplastypassport

2.6.2

Implantation

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect instruments for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the instruments. Implantation of the S4 Spinal System implant requires the following steps: ► Select the appropriate S4 Spinal System variant and anchoring implants according to the individual indication, preoperative planning and bone situation found intraoperatively.

WARNING Inadequate fixation due to incorrect positioning of the rod in the screw head, see Fig. A to D! ► 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 size 3.5 screwdriver. WARNING 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. ► For tightening the locking screws of the cross connector, always use the torque wrench and countering

instrument intended for this purpose. 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. CAUTION Rod connector is unusable if locking screws are removed or not present! ► Use another rod connector for implantation.

WARNING Inadequate fixation due to incorrect screw selection! ► Apply cannulated monoaxial screws when using FRI instruments.

► 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

► 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

► Always tighten the locking screws with the torque 4 N∙m wrench FW207R intended for this purpose.

orientation. WARNING Danger of screw breakage due to hard bone or contact with lateral cortex! ► Prepare the vertebral body over the entire screw length with thread cutter. WARNING 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. ► To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant com-

ponents. ► 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

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. ► 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 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. WARNING 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 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 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. WARNING 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 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.

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 N∙m torque wrench. WARNING 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 N∙m. 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. WARNING 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

tightening or loosening the locking screws. WARNING Risk of screw breakage caused by pedicle screws used for spondylolisthesis! ► Support the stabilization measure with an intercorporal fusion (ALIF, PLIF or TLIF). CAUTION 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.

3.

Validated reprocessing procedure

3.1

General safety instructions

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 processing of products. Note Mechanical processing should be favored over manual cleaning as it gives better and more reliable results. 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. Note Up-to-date information about processing and material compatibility can be found on the B. Braun eIFU site at eifu.bbraun.com The validated steam sterilization procedure was carried out in the AESCULAP sterile container system.

3.2

Service life

Set screws and rods The biocompatibility and processability was verified by the manufacturer after 500 cycles of repeated processing. The product can be processed up to 500 times with proper care and if it is undamaged and clean. Any additional reuse is the responsibility of the user. Careful visual and functional inspection before each use is the best opportunity to recognize a product that is no longer functional, see Inspection.

Pedicle screws and connectors The biocompatibility and processability was verified by the manufacturer after 180 cycles of repeated processing. The product can be processed up to 180 times with proper care and if it is undamaged and clean. Any additional reuse is the responsibility of the user. Careful visual and functional inspection before each use is the best opportunity to recognize a product that is no longer functional, see Inspection.

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.

3.3

Cleaning/Disinfection

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.

3.3.1

Product-specific safety information on the reprocessing method

3.5

► Use the implant system storage devices for processing, sterilization and sterile setup. ► Use a suitable tray for cleaning/disinfection. ► Use the system storage device only for sterilization and sterile provision. ► Ensure that the implant components do not come into contact with each other or with instruments in their

implant system storage devices/trays. ► Ensure that the implant components are not damaged in any way.

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/trays covered or closed. ► Process implant system storage devices/trays separately from instrument trays. ► Clean implants must not be cleaned together with contaminated implants. ► Reprocess the implant components individually and separately if no implant system storage devices are available, When doing this, make certain that the implant components are not damaged. ► 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.

3.3.2

Validated cleaning and disinfecting procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Do not clean with brushes or other abra-

Chapter Manual cleaning/disinfection and subchapter:

sives that would damage the product surface.

■ To prevent internal stresses and weaken-

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Chapter Manual clean-

ing of the implants, avoid scoring or scratching any components.

ing with ultrasound and immersion disinfection

■ Do not clean with brushes or other abra-

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

sives that would damage the product surface.

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Chapter Manual precleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

3.5.1

Manual pre-cleaning with ultrasound and brush

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

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

disinfecting procedure. 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.

3.5.2

Mechanical alkaline cleaning and thermal disinfecting

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

3.4

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of

the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

3.4.1

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, phenolfree, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenolfree, 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 fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

disinfecting procedure. 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.

– pH = 13 – < 5 % anionic surfactant

■ working solution 0.5% – 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: B. Braun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.6

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.6.1

Visual inspection

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts,

recessed areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products.

3.6.2

Functional test

► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside damaged or inoperative products.

3.7

Packaging

► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in AESCULAP sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during stor-

age.

3.8

Steam sterilization

► Validated sterilization process

– Steam sterilization using fractional 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 products 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.

3.9

Storage

► Store sterile packed implant components dust-protected in a dry, dark and temperature-controlled room.

4.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA011187

2022-07

Change No. AE0061814