BBraun
ABC plates 106 mm to 115 mm
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Aesculap® ABC ABC plates 106 mm to 115 mm Intended use The Aesculap ABC implants are used exclusively for the anterior multisegmental stabilization of the cervical spine in the region from C2 to Th1. They comprise: ■ Bone plate – for multisegmental provision, 106 mm to 115 mm long ■ Bone screws – bicortical, 10 mm to 28 mm long, ∅ 4.0 mm – monocortical, 10 mm to 18 mm long, ∅ 4.0 mm – Revision screws, 13 mm to 17 mm long, ∅ 4.5 mm – monocortical, 10 mm to 18 mm long, ∅ 4.0 mm, self-locking – Revision screws, 13 mm to 17 mm long, ∅ 4.5 mm, self-locking
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 metal fatigue. ■ The attending physician 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.
■ Damage to load-bearing bone structures can result in loosening of the components, bone or implant fractures or other acute 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. ■ 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
Materials 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 coated with a colored oxide. Slight changes in coloration may occur, but do not affect the implant quality. ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.
■ 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 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.
Indications
► Ensure that the implant components are not damaged in any way.
Surgically installed implants serve to support normal healing processes. 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
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.
Do not use in the presence of: ■ Fever ■ Infection: systemic or localized in the spine ■ 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
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.
Side effects and interactions
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:
■ Implant failure resulting from excessive load: implant bending, loosening, or breakage, poor fixation, no or delayed bone fusion, infection, or vertebral body fracture ■ Trauma 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 fragment 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
Safety notes This device is not intended for screw attachment or fixation to posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
– 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
■ 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 this documentation. ■ The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
WARNING
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 erroneous indication, wrong choice of implant, incorrect combination of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis. ■ The user instructions 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 excised components. ■ Implants that have been used before must not be reused.
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.
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 sort out 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 whilst in 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.
The various types of ABC screws are color-coded: ■ green = 4.0 mm monocortical ■ blue = 4.0 mm bicortical ■ pink = 4.5 mm revision screw ■ turquoise = 4.0 mm monocortical, self-locking ■ pink = 4.5 mm revision screw, self-locking ► Select ABC screws for correct type and length. ► Check the length of the ABC screw. ► To facilitate the intraoperative handling, temporarily fix the ABC plate on the vertebral bodies by means of a fixation pin (through the pinholes on the central line). This prevents the ABC plate from slipping out of place during the drilling procedure, and it allows an easier positioning of the drill holes and insertion of the ABC screws. ► Prepare the holes for the ABC screws using ABC drilling rules and ABC drills (2.7 mm diameter) only. Make sure that – the ABC drill is always used in connection with an ABC drilling rule, – the drilling rule is placed correctly in the plate hole. Damage to the ABC screw through incorrect handling of the screwdriver when screwing into the ABC plate! ► Fully insert the tip of the screwdriver into the screw head. CAUTION
Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Application
WARNING
Deficient locking of the ABC screw due to incomplete engaging in the hole of the ABC plate! ► Ensure that the ABC screw fully engages in the hole of the ABC plate. CAUTION
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. CAUTION
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 conversant 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 on 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 instruments provided by Aesculap. ► Please follow the instructions for use for the ABC instruments (TA009777/TA011777), the instructions for use for the fixation pins (TA009932) and the operating manual (Brochure no. O17702/O29602), except for the chapter concerning the plate bender. ► Please follow the instructions for use for the special ABC plate bender FJ842R (TA009977). ► Select implant components according to the 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. ► Select the length of the ABC plate according to the following criteria: – as short as possible – 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 ABC plates 106 mm to 115 mm have not been pre-bent according to natural cervical spine lordosis. They need to be adapted, by means of the special ABC plate bender FJ842R, to the anatomical conditions of the patient’s cervical spine. Note With the ABC plates 106 mm to 115 mm, bending should be carried out in steps (bending zone by bending zone) in order to avoid excessive or insufficient lordosation. Risk of injury through fracture of the ABC plate! ► Bend ABC plate 106 mm to 115 mm only with the special ABC plate bender FJ842R. WARNING
WARNING
Damage to, and breakage of, the ABC plate caused by excessive strain on the material! ► Always bend the ABC plate in one direction only. ► Do not bend back the ABC plate.
► Bend the ABC plate longitudinally and within the bending zone only. ► Avoid small bending radii, bending back and notching or scratching of the ABC plate.
Back out of the screw from the ABC plate through contact of the screw thread with the cage or bone graft! ► Ensure that the screw thread of the ABC screw is not in contact with the cage or bone graft on insertion.
► When using bicortical ABC screws, precut the thread with a screw tap. ► To insert ABC screws, use special insertion instruments. ► Position the ABC screw:
– in the cranial plate holes, as far cranial as possible, – in the caudal plate holes, as far caudal as possible, – for multisegmental provision (more than 4 plate holes) centrally in each of the inner plate holes. ► Fully screw in the ABC screw into the ABC plate. ► Secure the ABC screw against back-out by means of the ABC locking instrument. Note If self-locking screws are used, it is not necessary to secure the ABC screw against back-out by means of the ABC locking instrument. ► Check that the locking pin of the ABC screw is visible and sits flush with the screw head. ► Remove the temporary fixation pin.
CAUTION
CAUTION
Damage to the revision instrument and the ABC screw threw improper application! ► Never use the revision instrument to screw in or unscrew ABC screws. ► Only free-turning ABC screws, the screw heads of which will not snap out of the hole in the ABC plate, can be screwed in or unscrewed by means of the revision instrument.
Damage to the screw-out sleeve and the self-locking ABC screw if incorrectly applied! ► Unscrew fixed ABC screws only with the ABC screwdriver. ► Only free-turning ABC screws, of which the screw heads do not snap out of the hole in the ABC plate, should be removed with the screw-out sleeve for free-turning screws fitted on the screw-driver.
► To remove an implanted ABC screw:
– Push down the locking pin of the ABC screw with the ABC screwdriver. – Use the screwdriver to loosen the ABC screw. ► If the screw head, with the screw turning freely, does not snap out of the hole in the ABC plate, use the special revision instrument: – Insert the revision instrument, as far as it will go, into the slots between the screw head segments. – Remove the ABC screw by simultaneously pulling and turning it anticlockwise. – or – – Fit the screw-out sleeve for self-locking screws onto the screwdriver. – Guide the screwdriver with screw-out sleeve over the screw and insert the screwdriver tip fully into the screw. – Slide the screw-out sleeve forwards. – Remove the ABC screw by simultaneously pulling and turning it anticlockwise. 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!
TA-Nr. 009911
2017-11
V6
Änd.-Nr. 57595