A-Space SIBD implants

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

Aesculap® A-Space SIBD implants Intended use The A-Space SIBD Interbody Fusion System is a stand alone device intended to be used with four bone screws if no supplement fixation is used to stabilize the lumbar spine through an anterior approach. The system contains: ■ Cages in different heights, angles and footprints ■ Bone screws in different lengths

Materials The materials used in the implant are listed on the packaging: ■ The A-Space SIBD PEEK cages are made of PEEK-OPTIMA®. They contain marker pins made of tantalum to ensure radiological visibility for inspecting the implant position ■ The SIBD bone screws are made of 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® is a registered trademark of Aesculap AG, 78532 Tuttlingen/Germany. PEEK-OPTIMA® is a registered trademark of Invibio, Ltd Lancashire FY5 4QD/UK.

■ 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. ■ 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 attending physician shall make any decision with regard to the removal of implant components that have been used. ■ 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. ■ A precise diagnosis requires X-rays taken in the direction anterior-posterior and medial-lateral. ■ 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 Indications

■ The A-Space SIBD PEEK cages come individually packed in protective packaging that is labeled according to its

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 disc disease (DDD) and instability ■ Spondylolisthesis up to Grade 1 ■ Post-discectomy syndrome ■ Post-trauma instability Levels of anterior lumbar interbody fusion for these indications are from L2-S1.

■ The A-Space SIBD PEEK cages are gamma-sterilized.

content.

► 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 expiry date or whose packaging is damaged.

Damage to implants caused by processing and resterilization! ► Do not reprocess or resterilize the implants.

Contraindications

WARNING

Do not use in the presence of: ■ Fever ■ Acute or chronic infections or severe defects of the osseous structures of the vertebral bodies, which need to be sound for the stable implantation of the A-Space SIBD implants ■ Bone tumors in the region of implant fixation ■ Wound healing disorders ■ Osteoporosis or osteopenia ■ Medical or surgical conditions that could negatively affect the outcome of the implantation ■ Pregnancy ■ Adiposity ■ Systemic or metabolic illnesses ■ Mental illness ■ Neuromuscular disorders or illnesses ■ Foreign body sensitivity to the implant materials ■ Dependency on pharmaceutical drugs, drug abuse, or alcoholism ■ Generally poor condition of the patient ■ Inadequate patient compliance ■ Cases not listed under indications

■ The SIBD bone screws are supplied in an unsterile condition. ■ The SIBD bone screws are packaged individually.

Side effects and interactions

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.

The surgical intervention involves the following potential risks: ■ Neurological complications caused by overdistraction or trauma of the nerve roots or dura ■ Loss of intervertebral disk height due to removal of healthy bone material Complications that can generally occur in connection with intervertebral surgery: ■ Pseudarthrosis ■ Incorrect implant position ■ Spondylolisthesis ■ Loss of fixation; dislocation or migration ■ Implant failure resulting from excessive load ■ 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 ■ Impairment of the gastrointestinal, urological, and/or reproductive systems ■ 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 ■ Death

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

tive packaging immediately prior to processing. ► Use a suitable tray for cleaning/disinfection. ► Use the system storage device only for sterilization and sterile provision.

For implant components in original packaging: ► 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: 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 Sterilization should always be favored over disinfection under all circumstances. Only if final sterilization is not possible should disinfection with a virucidal agent be preferred. Note For the latest information on 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* 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

Safety notes 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 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.

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:

WARNING

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.

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.

► Confirm anatomically suitable position and orientation of the A-Space SIBD cage. ► Select the appropriate length and number of SIBD bone screws. ► Insert the screws under X-ray control, especially the diverging lateral screws.

WARNING

Engaging the screwdriver incorrectly when turning the screw into the A-Space SIBD cage may result in damage to the bone screws! ► Fully insert the tip of the screwdriver into the bone screw. WARNING

WARNING

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.

Applying too high torque may result in damage to the bone screws and the ASpace SIBD cages! ► Always use the A-Space SIBD/ArcadiusXP_L screwdrivers with torque limiting handle.

► Insert the bone screws until they reach the final seated position, ensuring full engagement of the two locking

mechanisms. Backing out and loosening of the bone screw occurs when the screw is not fully inserted into the cage! ► Insert the bone screw until it gets fully engaged.

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.

Risk of insufficient stability or implant failure due to using fewer than four screws! ► Apply all four screws or use an additional supplemental spinal fixation system such as the Aesculap S4® Spinal System.

WARNING Note If a fully seated bone screw is removed from the implant, a small piece of PEEK debris from the locking rim in the locking mechanism may be present. Note Implant removal can give rise to complications due to implants that are stuck, ingrown bone tissue, etc. Such complications can lead to damage to implants and/or instruments. For such cases we recommend using a set of special instruments, which can be ordered from Aesculap. This instrument set should be at hand for every explantation. Other special instruments are available for dealing with broken implants. Note the instructions for use for such case! Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate B. Braun/Aesculap office.

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

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging.

Application

WARNING

TA-Nr. 013175 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.

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. ■ 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: ■ The implant can come loose due to excessive load, wear and tear, or infection. ■ The lifespan of the implant depends on the patient’s body weight and the strain to which the joint is subjected. ■ The implant components must not be overstrained by extreme loads, hard physical labor or sporting activities. ■ Corrective surgery may become necessary if the implant loosens. ■ The patient must undergo medical follow-up examinations of the prosthetic joint at regular intervals. ■ Smokers present an increased risk of bone fusion failure Implantation of the A-Space SIBD implant system implant requires the following steps: ► Only use A-Space SIBD instruments provided by Aesculap. ► Follow the instructions of use of the A-Space SIBD instruments and the O.R. manual. ► Select the appropriate A-Space SIBD spacer size and shape according to the individual indication, preoperative planning and bone situation found intraoperatively. ► To avoid internal stresses and weakening of the implant: avoid scoring and scratching of the implant components. ► Apply the preparation and implantation instruments correctly.

WARNING

Risk of migration and subsidence due to overpreparation of the vertebral body endplates! ► Make certain that the base and cover plates of the adjacent vertebral bodies are not weakened.

► Check spacer height and/or angle using the trial spacers. ► Before inserting the cage it is recommended to fill it with bone or bone substitute. ► Apply appropriate care when inserting the implant.

WARNING

WARNING

Inaccurate marking of the midline may result in incorrect positioning of the implant! ► Always mark the midline under X-ray visualization. ► Determine the center of the vertebral disc using the midline marker, under Xray visualization. If the implant is inserted too deep, the spinal canal and other posterior elements may be compressed! ► Always use the A-Space SIBD/ArcadiusXP_L implant inserter/manipulator with a depth stop.

2017-12

V6

Änd.-Nr. 58030