ArcadiusXP C spinal system Instructions for Use

Aesculap® ArcadiusXP C spinal system Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at https://extranet.bbraun.com

Intended use The ArcadiusXP C spinal system is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from C2 to T1 in skeletally mature patients. The ArcadiusXP C cervical cage must be used with the two internal screw fixations provided. If no fixation is used the system must be used with supplemental fixation systems that have been cleared for use in the cervical spine, such as cervical plating systems. The ArcadiusXP C spinal system is designed for use with autogenous bone graft material to facilitated fusion and is implanted via an anterior approach. Surgically installed implants serve to support normal healing processes. They are not intended to either replace normal structures of the human body or to permanently bear the loads they would be subjected to in case of incomplete healing. The ArcadiusXP C spinal 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 ArcadiusXP C cervical cages are made of PEEK-OPTIMA® LT1 in accordance with ASTM F2026, and coated with a pure titanium layer in accordance with ISO 5832-2 or ASTM F1580 and a vacuum plasma spray coating (PLASMAPOREXP®). They contain marker pins made of titanium alloy to enable radiographic visualization for placement and follow-up evaluations. ■ The bone screws and marker pins are made of surgical implant applications titanium alloy Ti6Al4V according to ISO 5832-3 or ASTM F136. The titanium bone screws are anodized with a colored oxide layer. Slight changes in coloration may occur, but do not affect the implant quality. PLASMAPORE® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany. PEEK-OPTIMA® is a registered trademark of Invibio, Ltd Lancashire FY5 4QD / UK.

Indications Use for the following indications: ■ Cervical degenerative disc disease (DDD) ■ Post-traumatic instability and instability resulting from degenerative disc diseases ■ Corrections of spinal static disorders ■ Post-discectomy syndrome Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device.

Contraindications Any medical or surgical condition that could preclude the potential success of the implantation. These include: ■ Existing or risk of acute or chronic infections, fever/leukocytosis ■ Progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation ■ Severe defects of the bony structures of the spine which are a prerequisite for stable implantation of the cages ■ Bone tumors in the region of the implant anchoring ■ Proven or suspected allergy/foreign body reactions to implant materials ■ Conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient ■ Patients resistant to following post-operative restrictions on movement, especially in athletic and occupational activities ■ Systemic, metabolic and degenerative diseases ■ Psychosocial problems; unwillingness or inability of the patient to follow the instructions for post-operative treatment ■ Drug abuse or alcoholism ■ Generally poor condition of the patient ■ Prior fusion at the level(s) to be treated ■ All cases that are not listed under “Indications”

Side effects and interactions In addition to surgery-related risks, potential complications in connection with intervertebral procedures can include, but are not limited to: ■ Disassembly, bending and/or fracture of the implants or instruments ■ Early or late loosening of the components ■ Failure of the device to provide adequate mechanical stability ■ Loss of fixation ■ Implant migration/dislocation ■ Malpositioning of the implant ■ Subsidence of the device into vertebral body(ies) ■ Foreign body reactions, allergy ■ Nonunion or delayed union ■ Infection ■ Increase in biomechanical stress on adjacent levels ■ Nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, appearance or radiculopathy, and/or the development or continuation of pain, paralysis (complete or incomplete), pseudomeningocele, cerebral spinal fluid leakage, dysesthesia, hyperesthesia, anesthesia, paresthesia, numbness, neuroma, tingling sensation, sensory loss and/or spasms ■ Skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications ■ Spondylolisthesis, pseudoarthrosis, inadequate integration of the implant ■ Changes in bone density, degenerative changes in the region of the adjacent vertebral bodies ■ Bone loss due to resorption or stress shielding, or bone fracture at, above or below the level or surgery (fracture of the vertebra) ■ Hemorrhage of blood vessels, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood vessels, or cardiovascular system compromise

■ Wound necrosis or wound dehiscence ■ Herniated nucleus pulposus, disc disruption or degeneration above/below the level of surgery ■ Scar formation possibly causing neurological compromise around nerves and/or pain ■ Gastrointestinal complications ■ Misalignment of anatomical structures, including loss of proper spinal curvature, correction, reduction and/or height

■ Loss of spinal mobility or function ■ Loss of intervertebral disk height due to removal of healthy bone material ■ Changes of the normal spine lordosis ■ Wound healing problems ■ Pain or discomfort at the operative and/or bone graft donor site ■ Meningitis ■ Discomfort or abnormal sensations due to the presence of the device ■ Limited performance ■ Persistence of symptoms that were to be treated by the implantation ■ Inability to resume activities of normal daily living ■ Reoperation ■ Death

Safety notes

CAUTION

Damage to the PLASMAPOREXP® cages through the use of high frequency surgical devices! ► Avoid using high frequency surgical devices in proximity to the implant. ► If the implant is damaged: Remove the implant.

■ Only patients that meet the criteria described in the indications should be selected. ■ 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.

■ 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. ■ 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 use instruments belonging to another system or made by another manufacturer. ■ Do not, under any circumstances, use damaged or surgically removed components. ■ Implants that have been used before must not be reused. ■ 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. ■ Post-operatively, individual patient information, as well as mobility and muscle training, is of particular importance. Precaution: The ArcadiusXP C spinal system has not been evaluated for safety and compatibility in the MR environment. The ArcadiusXP C spinal system has not been tested for heating or migration in the MR environment ■ Delayed healing can cause implant breakage due to material fatigue. ■ The attending surgeon decides whether implant components should be explanted, taking into account the potential risk of another surgery and the difficulties involved in the removal of an implant. ■ Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migration, and other severe complications. ■ In order to promote the earliest possible detection of any problems or complications, the operation results must be followed up at regular intervals with the aid of appropriate examination procedures. A precise diagnosis requires X-rays taken in the directions anterior-posterior and medial-lateral.

Sterility ArcadiusXP C cages ■ The ArcadiusXP C cages come individually packed in protective packaging that is labeled according to its contents. ■ The ArcadiusXP C cages 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 ArcadiusXP C cages. WARNING

ArcadiusXP C bone screws ■ The ArcadiusXP C bone screws are supplied in an unsterile condition. ■ The ArcadiusXP C bone screws 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 processing. ► 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: 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 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 ► Process the ArcadiusXP C bone screws in their system storage device. ► 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]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

3

D–W

-

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

The patient has been informed of the procedure, taking into account the information provided in the sections on indications, contraindications, side effects and interactions, and has documented his/her understanding and consent regarding the following points: ■ In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads and material fatigue. ■ The implants can come loose or break under increased load. Factors such as the patient’s body weight, their level of activity and their compliance with instructions concerning their bearing of weight or loads can influence the durability of the implant. ■ To allow maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical vibrations that may loosen the device construct. Physical activities must be limited and restricted, especially lifting, twisting motions and any type of sport participation. ■ Corrective surgery may become necessary if the implant loosens. ■ Patients with previous spinal surgery at the levels to be treated may not experience the same clinical outcomes as those without a previous surgery. ■ Smokers present an increased risk of bone fusion failure. ■ The patient must undergo medical check-ups of the implant components at regular intervals. ■ The patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion. Implantation of the ArcadiusXP C spinal system requires the following steps: ► Only use ArcadiusXP C instruments provided by Aesculap. ► Follow the instructions for use of the ArcadiusXP C instruments and the O.R. manual. ► Select the appropriate ArcadiusXP C cage size and shape according to the individual indication and preoperative planning. Note The correct selection, placement and fixation of the ArcadiusXP C system components is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant. The size and shape of the human spine presents limiting restrictions of the size and strength of implants. ► Prior to use: Unpack the ArcadiusXP C implants and inspect them for damage. ► Ensure that the implants are protected from being marred, nicked, scratched or notched as a result of contact

with metal or abrasive objects. Note Alterations will result in defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. ► Apply the preparation and implantation instruments correctly.

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

WARNING For ArcadiusXP C bone screws that are to be resterilized:

► Check spacer height and/or angle using the trial implants.

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.

Note Prior to inserting the cage it is recommended to fill it with bone or bone substitute. The coated surfaces of the ArcadiusXP C cage may be damaged by improper handling! ► Avoid direct contact with the coated surfaces. ► Handle implants carefully.

WARNING

► Do not use excessive force when introducing and positioning the implant within the intervertebral body space

to avoid damaging the implant. 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 under X-ray visualization using the midline marker.

WARNING

If the implant is inserted too deeply, the spinal canal and other posterior elements may be compressed! ► Always use the ArcadiusXP C all-in-one guides for interbody with a depth stop.

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

WARNING ► Confirm the anatomically suitable position and orientation of the ArcadiusXP C cage. ► Select the appropriate length of bone screws. ► Insert the bone screws under X-ray control.

Risk of insufficient stability or implant failure due to using fewer than the two internal screw fixations provided! ► Apply both screws or use an additional supplemental spinal fixation system that has been cleared for use in the cervical spine, such as cervical plating systems.

WARNING

► 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.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area. ► Ensure that the implants do not get scratched or otherwise damaged. Protect implants and instruments during

Engaging the screwdriver incorrectly when turning the bone screw into the ArcadiusXP C cage may result in damage to the bone screws! ► Fully insert the tip of the screwdriver into the bone screw. WARNING ► 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 is fully engaged.

storage, especially from corrosive environments.

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. ■ All instruments must be cleaned and sterilized prior to surgery. ■ 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 familiar 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.

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. Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate B. Braun/Aesculap office. TA-Nr. 018000

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V6

Änd.-Nr. 55646