ABC E-Plate

Safety notes Aesculap® ABC E-Plate Intended use The Aesculap ABC- plate and screw system is intended for the monosegmental and multisegmental treatment of cervical spine instability caused by: ■ Degenerative disk disease (DDD - defined asdiskogenic pain with degeneration of the intervertebral disk confirmed by history and radiographic studies) ■ Trauma (including fracture) ■ Post-traumatic kyphosis or lordosis ■ Tumors ■ Reoperation necessitated by prior fusion failure For this indication, screws can be fixated in the region C2 to T1. Aesculap ABC E-Plates E-Plates (extension plates) are used exclusively for the monosegmental or bisegmental extension of a previous cervical spine stabilization with the ABC system in spine region C2-T1. The following ABC E-Plates are available: ■ Bone plates – for monosegmental cranial extensions, 10-14 mm long – for monosegmental caudal extensions, 12-16 mm long – for monosegmental cranial extensions, 23-32 mm long – for monosegmental caudal extensions, 23-35 mm long ■ ABC system bone screws are also required for fixation of the ABC E-Plates: – bicortical, 10-28 mm long, ∅ 4.0 mm (blue) – monocortical, 10-18 mm long, ∅ 4.0 mm (green) – revision screws, 13-17 mm long, ∅ 4.5 mm (pink) – monocortical, 10-18 mm long ∅4.0 mm, self-locking (turquoise) – revision screws, 13-17 mm long, ∅ 4.5 mm, self-locking (fuchsia)

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO5832-3 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.

Indications Surgically installed implants are designed to support the normal healing process. They are not intended to replace normal body structures nor to permanently bear loads in cases where healing does not occur. ABC implants require additional support, a bone graft for instance. Use for the following indications: ■ Degenerative diseases of intervertebral discs – Diminished height of an intervertebral disc – Bridging of the vertebral end plates – Build-up of osteophytes and/or excrescences with a thickening of the ligament structures ■ Deformities ■ Post-trauma instability ■ Fractures ■ Tumors ■ Reoperations necessitated by pseudarthroses

Contraindications Do not use in the presence of: ■ Fever ■ Infection – systemic – in the spine – localized ■ Pregnancy ■ Medical or surgical conditions that could negatively affect the outcome of the implantation ■ Foreign body sensitivity to the implant materials ■ Acute osteopenia ■ Severe osteoporosis or similar loss of bone density ■ Severe damage to the osseous structures preventing fixation of the implant components ■ Systemic or metabolic diseases ■ Dependency on pharmaceutical drugs, drug abuse, or alcoholism ■ Morbid obesity (adiposity) ■ Generally poor condition of the patient ■ Inadequate patient compliance ■ Cases not listed under indications

Side effects and interactions ■ 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 ■ Neurological complications due to overdistraction ■ Trauma to nerves or vessels ■ Loss of disk height due to the removal of load-bearing bone material ■ Pseudarthrosis ■ Bone graft resorption ■ Spondylolisthesis ■ Tissue reaction to the implant materials ■ Bone atrophy or diminished bone density ■ Reduced joint mobility and flexibility ■ Arthralgia and reduced tolerance for exercise

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 affixed 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.

■ 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 surgeon in charge of the therapy shall make any decision with regard to the removal of implant components that have been used. In this case he must be conscious of the potential risks of a further operation as well as of the difficulties of an implant removal. ■ 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 the weight-bearing bone cement and/or bone structures can cause loosening of the components, fracture of the bone or implant and other grave 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 ■ The implant components are supplied in an unsterile condition. ■ The implant components are packaged individually. ► Store implant components in their original packaging and remove from their original protective wrapping only

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

Application

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]

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 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! ► Carry out the final rinse with distilled, demineralized, or fully desalinated water. ► Always observe the applicable hospital guidelines concerning the supply of sterile materials. Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood, body tissue or bodily fluids.

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.

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 possesses detailed knowledge of cervical spine stabilization and the biomechanical principles of the cervical spine ■ 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 patient is aware of the risks involved in neurosurgery, general surgery, orthopedic surgery, and general anesthesia. ■ The patient has been informed of the advantages and drawbacks of implants and has been made aware of possible alternative methods of treatment. ■ 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 subjected to overload or to extreme strains from physical labor or sports activities. ■ 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. The implantation of the ABC system requires the following application steps: ► Only use ABC and ABC E-Plate instruments provided by Aesculap. ► Observe the instructions for use for the ABC instruments (TA009777/TA011777), the fixation pins (TA009932) and the ABC E-Plate instruments (TA011800) ► Observe the operating manuals for the ABC (brochure no. O17702/O29602) and ABC E-Plates. ► Select implant components according to indication, preoperative planning, and the bone situation found intraoperatively. ► Be sure that stainless steel and titanium components are not combined in one spinal construct. ► To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant components. ► Only attach an ABC E-Plate to a previously implanted ABC plate/ABC E-Plate that has achieved the desired fusion. Never string together several new ABC E-Plates during an operation. ► Only use ABC E-Plates in the C2 to T1 area. The length labeled on the ABC E-Plate is the length of the E-Plate when integrated with the pre-existing ABC plate. The ABC E-Plate, including the claw attachment, is therefore approximately 10mm longer than the imprinted length. ► Select the length of the ABC E-Plate according to the following criteria: – as short as possible – taking into account the length of the claw attachment – enclosing the area to be fixed – allowing for axial settling Note The final determination of the implant length mostly takes place during the operation. The lordosis of the bisegmental ABC E-Plates must be adapted to the circumstances or the intended curvature of the spine. Note Only the bisegmental ABC E-Plates contain bending zones. To adapt these plates to the patient's anatomy, you must use the ABC plate bender. The contour of the ABC E-Plate's claw attachment has already been adapted to anatomical conditions and must not be bent under any circumstances. Damage to, and breakage of, the ABC E-Plate caused by excessive strain on the material! ► Do not under any circumstances bend the monosegmental ABC E-Plate. ► Bend the bisegmental ABC E-Plate only inside the bending zone and only in one direction. ► Do not bend the bisegmental ABC E-Plate back.

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.

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

WARNING

► Always use the plate bender FJ826R to bend a ABC E-Plate. ► Bend the ABC E-Plate longitudinally and within the bending zone only. ► Avoid small bending radii, bending back and notching or scratching of the ABC E-Plate. ► Adapt the cranial ABC E-Plate only at the cranial end of the ABC plate. ► Adapt the caudal ABC E-Plate only at the caudal end of the ABC plate. ► Always push the ABC E-Plate completely onto the ABC plate. ► Never use the ABC revision screw for the additional hole in the caudal ABC E-Plate. ► When inserting ABC screws, follow the directions provided in the instructions for use of the ABC instruments

(TA009777/TA011777). ► For subsequent implantation steps, observe the instructions for ABC E-Plate instruments (TA011800).

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!

Distributor in the US/Contact in Canada for product information and complaints Aesculap Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 011799

2017-12

V6

Änd.-Nr. 58122