SPINE System Evolution Instructions for Use

■ The attending physician shall make any decision with regard to the removal of implant components that have been used, 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.

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Aesculap SPINE System® Evolution WARNING

Intended use The SPINE System® Evolution implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar and thoracic spine. They comprise: ■ Pedicle screws ■ Rods ■ Hook ■ Connecting discs ■ Sacral discs ■ 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.

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO 5832-3 ISOTAN® and the SPINE System® Evolution are registered trademarks 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 if healing does not occur. Use for: ■ Degenerative instability ■ Post-discectomy syndrome ■ Spondylolisthesis ■ Kyphosis ■ Scoliosis ■ Stenosis ■ Post-trauma instability ■ Tumors Risk of screw breakage caused by pedicle screws used for spondylolisthesis! ► Support the stabilization measure with interbody fusion (ALIF, PWF or TLIF). WARNING

Contraindications Do not use 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 affect the outcome of the implantation ■ Inadequate patient compliance

Side effects and interactions The application or improper use of this system entails the following risks: ■ 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

Safety notes ■ General risk factors associated with surgical procedures are not described in in the present instructions for use. ■ The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques.

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

Sterility ■ The implant components are supplied in an unsterile condition. ■ The implant components are packaged individually. ► Store the implant components in their original packaging and only remove them from their original and protec-

tive packaging immediately prior to application. ► 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 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 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 permitted load specified by the manufacturer for the steam sterilizer is not exceeded.

Application 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 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. ■ 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. ■ Information has been obtained from the manufacturer in the event of an ambiguous preoperative situation and if implants are present in the area to be treated 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. Implantation of the SPINE System® Evolution implant requires the following steps: ► Select the suitable SPINE System® Evolution version and anchoring implant on the basis of the indication, the preoperative planning and the bone situation found during the operation. ► When selecting the SPINE System® Evolution screw types, make certain to select the correct diameter, length, and canal orientation.

implantation.

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.

■ 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 instructions for use for individual Aesculap implant components must be followed. ■ 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 that have been used before must not be reused. ■ Damage to load-bearing bone structures can result in loosening of the components, bone or implant fractures or other acute complications. ■ To ensure the earliest possible detection of such implant dysfunction, the prosthetic joint must be checked periodically, using appropriate techniques. ■ Do not use instruments belonging to another system or made by another manufacturer. ■ Delayed healing can cause implant breakage due to material fatigue. ■ The attending physician shall make any decision with regard to the removal of implant components that have been used. ■ 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.

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 connecting discs of the SPINE System® Evolution. ► Do not bend back, or bend excessively, the rods and connecting discs. ► Only use the bending instruments of the SPINE System® Evolution instrument set for bending the rods and con-

necting discs. ► When using clamping elements (hook, retaining hook and connecting pin) use specialized mounting instruments.

WARNING

Risk of injury due to improper mounting of the clamping screw! ► Set the clamping screw in place correctly. ► Make certain that the rods are correctly positioned on the floor of the groove. ► Make sure that the clamping screw is fully tightened.

► When positioning the nut, use the repositioning lever as a guide.

► Reposition if necessary, being sure to use instruments correctly when doing so.

WARNING

Injury can result from nuts with insufficient clamping stability! ► Set nuts in place correctly. ► Make certain that the rods are correctly positioned on the floor of the groove. ► Tighten the nut down without the repositioning lever.

► When applying a polyaxial screw, set polyaxial clamping screw in place.

WARNING

Injury can result from the polyaxial screw with insufficiently tightened clamping screw! ► Set the clamping screw in place correctly. ► Make sure that the clamping screw is well tightened.

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. 009679

2017-12

V6

Änd.-Nr. 57966