MACS TL polyaxial screw XL

■ 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.

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Aesculap MACS TL® MACS TL® polyaxial screw XL Intended use The MACS TL® polyaxial screw XL is used in combination with the other MACS TL® implants, the MACS TL® system and the MACS II instrument set with pre-assembled retaining screw SX804T for the ventral monosegmental and multisegmental stabilization of the lumbar and thoracic spine. Note Use pre-assembled retaining screw SX804T only with the MACS II instrument set, see instructions for use TA013373.

■ 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. ■ Delayed healing can cause implant breakage due to material fatigue. ■ 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.

■ Damage to load-bearing bone structures can result in loosening of the components, bone or implant fractures

The MACS TL® system consists of: ■ Anchoring screws for the vertebral bodies ■ Tensioning elements ■ Fixation nuts and clamping screws ■ Connecting plates and, if required, connecting rods of the Aesculap Spine System Evolution, diameter 5.2 mm, as connection elements

or other acute complications. In order to detect any such problems as soon as possible, the condition of the implant must be followed up at regular intervals postoperatively with the aid of appropriate examination procedures. ■ The surgeon in charge of the therapy shall make any decision with regard to the removal of implant components that have been used, taking into account the potential risks of another operation and the difficulties involved in the removal of an implant.

Materials

Sterility

The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO 5832-3 MACS TL® and ISOTAN® are registered trademarks of Aesculap AG, 78532 Tuttlingen / Germany.

System configurations The MACS TL® system is available as a polyaxial twin-screw system with plate or 2 rods, see Fig.

■ 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. ► 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:

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: ■ Fractures ■ Spinal tumor ■ Degenerative disc disorder (spondylolisthesis, spondylolysis, spinal stenosis) ■ Post-trauma instability

Contraindications 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 Note In case of osteopenia, the surgeon must weigh up the risks that could jeopardise the therapeutic success of the MACS TL® system. If it is to be expected that the standard screw shall not provide sufficient stability, the polyaxial screw XL can be used.

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

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 Mechanical alkaline cleaning and thermal disinfection ► Process the implant in its system storage device.

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 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 For implant components that are to be resterilized:

CAUTION Federal law restricts this device to sale by, or on order of a physician! This system is not licensed to be screwed onto, or fastened to, the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. 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. 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 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.

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. ► Mechanically clean and disinfect the implant components. ► 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.