Anterior Stabilization System

■ 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.

Aesculap® MACSTL® Anterior Stabilization System

■ 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

Intended use

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

or other acute complications.

The MACS TL® implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar and thoracic spine. They comprise: ■ Anchoring screws for the vertebral bodies ■ Tensioning elements ■ Fixation nuts and clamping screws ■ Connecting plates and, if necessary, rods of the Aesculap SPINE-System® Evolution with a diameter of 5.2 mm as connecting elements System configurations: ■ Polyaxial twin-screw system with plate or 2 rods (see Fig. 1) ■ Polyaxial HMA system with plate or 2 rods (see Fig. 2) ■ Monoaxial HMA single-rod system (see Fig. 3)

using appropriate techniques. 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. WARNING

■ 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.

■ 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

Materials

number and serial number (if available) must be documented in all patient records.

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

System configurations

■ 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 the implant components in their original packaging and only remove them from their original and protec-

tive packaging immediately prior to application.

CAUTION

System incompatibility may result in increased operating time or abortion of the procedure! ► Follow only instructions for use TA013373 when using the pre-assembled retaining bolt SX804T.

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 polyaxial twin-screw system in case of: ■ Fractures ■ Spinal tumor ■ Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis) ■ Post-trauma instability Use polyaxial HMA system, with intact posterior column, in case of: ■ Spinal tumor ■ Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis) ■ Post-trauma instability Use monoaxial HMA system in case of: ■ Anterior correction of spinal deformities

Contraindications 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 in the presence of: ■ 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 ■ Severely 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

► Use a suitable tray for cleaning/disinfection. ► 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 If there is no final sterilization, then a virucidal disinfectant must be used. 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 Mechanical alkaline cleaning and thermal disinfection ► Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots).

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*

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 CAUTION Federal law restricts this device to sale by, or on order of a physician! To prevent corrosion, do not use this system in conjunction with other materials. ■ 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 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. ■ 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. ■ Aesculap is not responsible for any complications arising from wrong indication, wrong choice of implant, incorrect combination of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis.

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

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

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 set aside damaged or inoperative products.

Packaging ► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Make sure that the packaging will prevent a recontamination of the product during storage.

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.