MACS II Anterior Stabilization System

Safety notes Aesculap® MACS II Anterior Stabilization System

The MACS II Anterior Stabilization System is not licensed to be screwed onto, or fastened to, the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Note To prevent corrosion, do not use the MACS II Anterior Stabilization System in conjunction with other materials. 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 MACS II implants are used for ventral monosegmental and multisegmental stabilization of the lumbar and thoracic spine. They comprise: ■ Anchoring screws for the vertebral bodies ■ Tensioning elements ■ Locknuts ■ Pre-assembled retaining bolt SX804T ■ Connecting plates and, if required, connecting rods of the Aesculap Spine System Evolution, diameter 5.2 mm, as connection elements A special instrument set is required to implant these elements.

WARNING

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ General risk factors associated with surgical procedures are not described in this documentation. ■ The operating surgeon must have a thorough understanding 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.

■ It is the operating surgeon's responsibility to ensure the correct combination of implant components and their implantation.

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO5832-3 ■ ISOTAN®P pure titanium acc. to 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. MACS TL® and ISOTAN® are registered trademarks of Aesculap AG, 78532 Tuttlingen / Germany.

System configurations

CAUTION

System incompatibility may result in increased operating time or abortion of the procedure! ► Follow only these instructions for use when using the pre-assembled retaining bolt SX804T. ► Do not use MACS II in conjunction with the HMA monoaxial or polyaxial screws of MACS TL®.

■ Polyaxial Twin Screw system TL with plate or 2 rods, see Fig. 1. ■ Polyaxial Twin Screw system T with plate or 2 rods, see Fig. 2. ■ Polyaxial Twin Screw system XL with plate or 2 rods, see Fig. 3.

Indications Surgically installed implants are designed to support the normal healing process. They are not intended for use either as replacements for natural body parts or to bear loads over the long term if healing does not occur. Use for: ■ Fractures ■ Spinal tumor ■ Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis) ■ Post-trauma instability

CAUTION

Risk of screw breakage if anchoring screws are used on the vertebral bodies when performing a partial or total corporectomy! ► Support stabilization with intercorporeal fusion (vertebral implant or bone graft).

Cautionary Notes This system is not licensed to be screwed onto, or fastened to, the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. Do not use if the patient has: ■ Fever ■ Acute or chronic vertebral infections of a local or systemic nature ■ Pregnancy ■ Severe osteoporosis or osteopenia ■ Medical or surgical conditions that could negatively affect the outcome of the implantation ■ Severe damaged bone structures that could prevent stable implantation of implant components ■ Bone tumors in the region of implant fixation ■ Wound healing disorders ■ Inadequate patient compliance ■ Foreign body sensitivity to the implant materials ■ Cases not listed under indications

Side effects and interactions The application or improper use of this system may result in: ■ Implant failure resulting from excessive load – Warping or bending – Loosening – Breakage ■ Inadequate fixation ■ Failed or delayed fusion ■ Infection ■ Fractured vertebral body or bodies ■ Injuries to – Nerve roots – Spinal cord – Blood vessels – Organs ■ Changes of the normal spine lordosis ■ Impairment of the gastrointestinal, urological, and/or reproductive systems ■ Pain or indisposition ■ 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

■ 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 lack of asepsis. ■ The user must follow the instructions that accompany each of the Aesculap implant components. ■ 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 removed components. ■ Implants already used must not be reused. ■ Delayed healing can cause implant breakage due to metal fatigue. ■ The surgeon in charge of the therapy 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. ■ 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 Pre-assembled retaining bolt SX804T: ■ The implant components come individually packed in protective packaging that is labeled according to its contents. ■ The implant components are gamma-sterilized. ► Store implant components in their original packaging. Remove them from their original protective packaging only just prior to application. ► Prior to use, check the product expiry date and verify the integrity of the sterile packaging. ► Do not use implant components that are past their expiration date or whose packaging is damaged Damage to implants caused by processing and resterilization! ► Do not reprocess or resterilize the implants. WARNING Anchoring screws for the vertebral bodies, tensioning elements, locknuts, as well as connecting plates and rods: ■ The implant components are supplied in unsterile condition. ■ The implant components are packaged individually. ► Store the implant components in their original packaging and only remove them from their original and protective packaging immediately prior to application. ► Use the implant system storage devices for processing, sterilization and sterile setup. ► Ensure that the implant components do not come into contact with each other or with instruments in their implant system storage devices. ► 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 reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing 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 www.aesculap-extra.net. The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Validated reprocessing procedure Cleaning/disinfection Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Do not use brushes or other

Chapter Manual cleaning/disinfection and sub-chapter:

abrasives that would damage the product surfaces and could cause corrosion

■ To prevent internal stresses on, and weakening of the implants: avoid scoring or scratching of the implant components

■ Drying phase: Use a lint-free cloth or medical compressed air

■ Chapter Manual cleaning with ultrasound and immersion disinfection

Manual cleaning/disinfection

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

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-

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

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 cleaned together with contaminated implants. ► Reprocess 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. ► Mechanically clean and disinfect the implant components. ► Do not reuse surgically contaminated implants.

Application

WARNING

The MACS II system is described in detail in the OR manual. Detailed user instructions can be found in the product documentation. The OR manual can be ordered from the manufacturers at any time. 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

WARNING

Risk of injury due to unsuitable selection and incorrect position of anchoring screws! ► For a secure implantation of the anchoring screws, careful measurement of the vertebral body's diameter at the planned screw position and direction is crucial. ► A screw length smaller than the measured diameter has to be chosen.

The following conditions must be fulfilled prior to application: ■ All requisite implant components are ready to hand ■ Operating conditions are highly aseptic ■ The implantation instruments, including the special Aesculap implant system instruments, are complete and in working condition. ■ 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. 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 regular medical follow-up examinations of the implant components. The implantation of the MACS II system requires the following application steps: ► Select the suitable MACS II system version and anchoring implant on the basis of the indication, the preoperative planning and the bone situation found during the operation. ► Determine the optimum implant position of the MACS II system. ► Preposition the implant with Kirschner wires under X-ray control.

WARNING

Risk of injury if Kirschner wires are positioned incorrectly! ► Always use X-ray control when positioning Kirschner wires. ► Use X-ray control to constantly monitor the position of the Kirschner wires throughout the operation.

WARNING

Risk of injury if incorrect instruments are used! ► Never use the screw revision instrument to apply counterforce at the Kirschner wires. ► Only use the counter holder to apply counterforce at the Kirschner wires.

► Prepare the bone correctly, using cannulated instruments. ► To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant compo-

nents. ► Do not bend or warp any metal implants with the exception of the rods of the Aesculap Spine System Evolution. ► Do not re-bend the rods or bend them excessively. ► Use only the bending instruments from the MACS TL® instrument set to bend the rods. ► Mount the pre-assembled retaining bolt on the polyaxial elements using the special mounting instrument.

WARNING

WARNING

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood.

Risk of injury due to inability to apply the necessary counter torque when tightening the locknuts or retaining bolt! ► Make sure the retaining lugs of the centralizer engage fully in the appropriate grooves in the tensioning element.

Risk of injury if centralizer comes loose during the procedure! ► Mount the pre-assembled retaining bolt using the mounting block and mounting torque wrench and tighten to a torque of 1.8 Nm WARNING

Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Immediately sort out damaged or inoperative products.

Packaging ► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Sterilization ► Validated sterilization process

– Steam sterilization using 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 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.

► Insert the implant components using the special insertion instruments. ► Do not tighten or screw in the polyaxial screw completely; ensure that the tensioner element can still be moved. ► Prior to unlocking the insertion instrument, remove the Kirschner wire through the cannulated insertion element,

using the appropriate removal instrument. ► Remove the insertion instrument. ► When using a polyaxial element, ensure that the centralizers remain temporarily mounted on the tensioner ele-

ments. Risk of injury due to use of MACS TL® distraction and/or compression instruments! ► Do not use any MACS TL® distraction and/or compression instruments! WARNING

► Insert placeholder. ► Insert stabilizing plate or rods. ► Implant stabilizing plate and locknut in such a way that the inscribed side (top side) is visible for the user.

Injury can result from nuts with insufficient clamping stability! ► Set locknuts in place correctly. ► Using a torque wrench, tighten the locknuts to a torque of 15 Nm. WARNING Risk of injury if no or insufficient counterforce is applied using the counter holder! ► To apply a counterforce, always use the counter holder provided, ensuring that an absolute minimum of force is transferred to the spine. WARNING Damage to the implant caused by overtightening of the locknut! ► Always tighten the locknuts to the exact torque specified for this purpose. WARNING ► Use a ballpoint screwdriver to evenly tighten polyaxial anchoring screws further.

Ensure that the ballpoint screwdriver is lodged securely in the polyaxial anchoring screw! ► When further tightening the polyaxial anchoring screws, rotate each one no more than one full turn. ► Remove the ballpoint screwdriver from the rear section of the polyaxial anchoring screw by lightly rotating it left and right.

WARNING

► When using the Twin-Screw system, insert the stabilization screw using an appropriate aiming sleeve and screw

in to the positive stop.

WARNING

WARNING

Risk of injury due to use of unsuitable aiming sleeve, incorrect placement of the aiming sleeve, or failure to use an aiming sleeve! ► Use the thoracic aiming sleeve when using the thoracic tensioning element (see handle geometry). ► Use the lumbar aiming sleeve when using the lumbar tensioning element (see handle geometry). ► Ensure that the aiming sleeve is positioned above the hole for the stabilization screw in the tensioning element. ► Always use the suitable aiming sleeve to insert the stabilization screw. Risk of injury if the aiming sleeve becomes jammed in the centralizer as a result of severe angular misalignment between the approach direction and centralizer axis! ► A lumbar stabilization screw can be used to unscrew and remove a jammed aiming sleeve in a controlled manner.

► To lock the polyaxial screw, tighten the torque wrench to 10 Nm for two clicks. The first click causes the break-

off collar on the pre-assembled retaining bolt to break off; the second click releases the torque wrench at a torque of 10 Nm.

WARNING

Risk of injury caused by insufficiently tightened fixing screws of the polyaxial elements! ► Using a torque wrench, tighten the fixing screws to a torque of 10 Nm. ► The screwdriver for the retaining bolt must engage fully in the fixing screw to prevent it from slipping. ► The groove on the screwdriver to accommodate the retaining bolt must be completely covered by the guide tube. Risk of injury if the centralizer is left in the body! ► In the event of failure of the 10 Nm torque wrench, the retaining bolt can be locked using a ¼" T-handle grip.

WARNING

WARNING

Operating time may be increased as a result of incorrect application! ► Do not pull out the insertion instrument after the first click! ► Only pull out the insertion instrument after completion of the second click. ► Ensure that the insertion instrument does not slip off the tensioning element after the first click.

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!

TA-Nr. 013373

2017-12

V6

Änd.-Nr. 57994