Quintex plates and screws

Safety notes This system is not licensed to be screwed onto, or affixed to, the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Aesculap® Quintex® plates and screws WARNING

Intended use The Quintex® cervical plating system is used for the anterior monosegmental and multisegmental stabilization of the cervical spine. It consists of the following components: ■ Bone plates – Hybrid cervical plate – Dynamic cervical plate ■ Screws – Constrained bone screw (10 mm to 22 mm, ∅ 4.0 mm) – Semiconstrained bone screw (10 mm to 22 mm, ∅ 4.0 mm) – Dynamic bone screw (10 mm to 22 mm, ∅ 4.0 mm) – Constrained bone screw (11 mm to 19 mm, ∅ 4.5 mm) – Semiconstrained bone screw (11 mm to 19 mm, ∅ 4.5 mm) – Dynamic bone screw (11 mm to 19 mm, ∅ 4.5 mm) Special instruments are required to implant these components.

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO5832-3 ■ Phynox® cobalt alloy acc. to ISO 5832-7 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. Phynox® is a registered trademark of Imphy S.A., Paris / France.

■ 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 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. 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 physician in charge decides whether the implanted components should be removed again, taking the risks associated with a further operation and the difficulty of interventions to remove implants into account.

Indications Surgical implants serve to support normal healing processes. They should neither replace normal structures of the body nor bear loads on a permanent basis in the case of incomplete healing. Use for: ■ Degenerative disk disease (diskogenic pain with degeneration of the intervertebral disks confirmed by the patient's anamnesis and radiographic studies) ■ Trauma (including fractures or dislocations) ■ Post-traumatic kyphosis or lordosis ■ Tumors ■ Spondylolisthesis ■ Spinal stenosis ■ Deformity (scoliosis, kyphosis, and/or lordosis) ■ Pseudarthrosis following an unsuccessful spinal operation ■ Symptomatic cervical spondylosis ■ Instability following surgical intervention due to the indications listed above ■ Reoperations necessitated by prior fusion failure For these indications, screws can be fixated in the region C2 to T1.

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 ■ Mental illness ■ Dependency on pharmaceutical drugs, drug abuse, or alcoholism ■ Adiposity ■ Severely damaged bone structures that could prevent stable implantation of implant components ■ Neuromuscular disorders or illnesses ■ Bone tumors in the region of implant fixation ■ Wound healing disorders ■ Generally poor condition of the patient ■ Inadequate patient compliance ■ Foreign body sensitivity to the implant materials ■ Systemic or metabolic diseases ■ Anticipated overloading of the implant ■ Patients who are or are suspected of being allergic to nickel may experience sensitivity, as the Phynox® material does contain nickel ■ Cases not listed under indications

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 ■ Neurological complications due to overdistraction ■ Loss of intervertebral disk height due to the removal of load-bearing bone material ■ Pseudarthrosis ■ Resorption of bone chips ■ Spondylolisthesis ■ Tissue reaction to the implant materials ■ Bone atrophy or diminished bone density ■ Reduced joint mobility and flexibility ■ Limited physical ability and arthralgia

■ Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migration, and other severe complications.

■ 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.

■ 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 used must be documented in the patient records, identified by their respective article number and implant designation, as well as the batch number and serial number (if applicable).

Sterility ■ 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. ► 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 If there is no final sterilization, then a virucidal disinfectant must be used. 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]

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:

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 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.

WARNING

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 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 operating surgeon has detailed knowledge of cervical-spine stabilization and the biomechanical principles of the cervical spine. 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, orthopedics, 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 cases of delayed or incomplete fusion, the implants may break or loosen as a result of excessive strains. ■ The life-span of the implant depends on the patient’s body weight. ■ The implant components must not be overloaded by excessive strains, hard physical labor, or sports. ■ 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 Quintex® system requires the following application steps: ► Only use Quintex® instruments from Aesculap. ► Comply with the information contained in the instructions for use for Quintex® instruments (TA013377) and the operating manual (brochure number O91702). ► Select implant components according to the indication, preoperative planning, and the bone situation found intraoperatively. ► Make sure that high-grade steel and titanium components are not combined in one and the same spinal construct. ► In order to prevent internal stresses on, and weakening of the implants: do not notch or scratch implant components. The two types of Quintex® plate are marked with the following color coding: ■ Gold = dynamic Quintex® plate ■ Blue = hybrid Quintex® plate (constrained/semiconstrained) ► Select the correct Quintex® plate in terms of type and length. ► Select the length of the Quintex® plate according to the following criteria: – as short as possible – enclosing the area to be fixed – allowing for axial settling Note The length of the implant is usually finally determined during the operation. The curvature of the Quintex® plates can be adapted to circumstances or the intended curvature of the spine, if applicable. Note In order to prevent excessive or insufficient lordosation, long Quintex® plates should only be bent gradually.

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.

CAUTION

Damage to or breakage of the Quintex® plate caused by an impermissible load on the implant material! ► Always bend the Quintex® plate in one direction only. ► Do not bend back the Quintex® plate.

► Always use the Quintex® plate bender to bend a Quintex® plate.

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

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

Damage to the locking mechanism of the plate holes caused by incorrect bending of the plates. ► Only bend the plate in the area of the bone chip window. ► Never bend the plate right next to or on the plate holes.

► Only bend the plate longitudinally and in the area of the bone chip window. ► Avoid small bending radii, bending back, notching, and scratching of the Quintex® plate.

The various types of screw are marked with the following color coding: ■ Blue screw = ∅ 4.0 mm constrained screw, self-locking ■ Blue screw head, purple screw shaft = ∅ 4.5 mm constrained screw, self-locking ■ Green screw = ∅ 4.0 mm semiconstrained screw, self-locking ■ Green screw head, purple screw shaft = ∅ 4.5 mm semiconstrained screw, self-locking ■ Gold screw = ∅ 4.0 mm dynamic screw, self-locking ■ Gold screw head, purple screw shaft = ∅ 4.5 mm dynamic screw, self-locking ► Select the correct Quintex® screws in terms of type, diameter, and length. ► Check the length of the Quintex® screw.

Note The ∅ 4.5 mm screws are provided for use in cases where the ∅ 4.0 mm standard screws do not ensure a secure hold (e.g., in osteoporotic bone material or following overtightening of a standard screw). Note Quintex® constrained screws (blue ∅ 4.0 mm, blue/purple ∅ 4.5 mm) and Quintex® semiconstrained screws (green ∅ 4.0 mm, green/purple ∅ 4.5 mm) can be combined with the hybrid Quintex® plate (blue). Note Quintex® dynamic screws (gold ∅ 4.0 mm, gold/purple ∅ 4.5 mm) and Quintex® semiconstrained screws (green ∅ 4.0 mm, green/purple ∅ 4.5 mm) can be combined with the dynamic Quintex® plate (gold).

CAUTION

Damage to Quintex® constrained screws and Quintex® dynamic plates caused by combining inappropriate components together. ► The implants are color coded. Do not use constrained screws (blue or blue/purple) in conjunction with the dynamic plate (gold) under any circumstances; only use them with the hybrid plate (blue). ► Dynamic implants and hybrid implants are provided in separate trays. Never mix the two different implant trays up.

CAUTION

Damage to Quintex® dynamic screws and Quintex® hybrid plates caused by combining inappropriate components together. ► The implants are color coded. Do not use dynamic screws (gold or gold/purple) in conjunction with the hybrid plate (blue) under any circumstances; only use them with the dynamic plate (gold). ► Dynamic implants and hybrid implants are provided in separate trays. Never mix the two different implant trays up.

Note Semiconstrained screws (green or green/purple) can be used in conjunction with the dynamic plate (gold) and the hybrid plate (blue). ► In order to facilitate intraoperative handling, the Quintex® plate is temporarily fixed to the vertebral body by

means of a fixation pin (through the pin holes along the midline). This prevents any slipping of the Quintex® plate during the drilling procedure, and it allows for easier positioning of the screw holes and insertion of the Quintex® screws.

CAUTION

Damage to the Quintex® screw caused by the use of excessive force and torque when screwing in! ► For hard bone, always use a Quintex® drill and Quintex® tapper instead of the Quintex® corticalis centering tool.

► Prepare drill holes for the Quintex® screws using Quintex® drill guides with Quintex® drills (∅ 2.9 mm) or with

the Quintex® corticalis centering tool. Make sure that – the Quintex® drill or Quintex® corticalis centering tool (without the self-centering outer sleeve) is only used in conjunction with a Quintex® drill guide and – the drill guide or the self-centering Quintex® corticalis centering tool is positioned correctly in the plate hole. Damage to the Quintex® screw caused by incorrect handling of the screwdriver when screwing into the Quintex® plate! ► Fully insert the tip of the screwdriver into the screw head. CAUTION

CAUTION

Deficient locking of the Quintex® screw caused by incomplete engagement in the hole of the Quintex® plate! ► Ensure that the Quintex® screw fully engages in the hole of the Quintex® plate.

► Position of the Quintex® screw:

– in the cranial plate holes, as far toward the cranium as possible – in the caudal plate holes, as far toward the posterior as possible – for multisegmental provision (more than 4 plate holes), centrally in each of the inner plate holes ► Fully screw the Quintex® screw into the Quintex® plate. ► Check that the locking ring of the Quintex® screw is visible and sits flush with the screw head. ► Remove the temporary fixation pin as soon as the Quintex® plate is fixed with the Quintex® screws.

CAUTION

Damage to the screw extraction instrument and the self-locking Quintex® screw if incorrectly applied! ► Only release fixed Quintex® screws using the Quintex® screwdriver. ► Use the screw extraction instrument to remove only those freely rotating Quintex® screws whose screw heads cannot be picked up out of the Quintex® plate holes.

► To remove an implanted Quintex® screw:

– Push down the locking ring of the Quintex® screw with the Quintex® screwdriver. – Turn the screwdriver counterclockwise to release the Quintex® screw. ► If the screw head of the freely rotating screw cannot be picked up out of the Quintex® plate hole, use the special screw extraction instrument: – Insert the screw extraction instrument as far as possible into the screw head. – Insert the tip of the instrument with the left-hand thread as far as possible into the screw while turning it counterclockwise. – Remove the Quintex® screw from the plate hole by pulling and continuing to turn the instrument counterclockwise at the same time. Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the relevant B. Braun/Aesculap office.

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

TA-Nr. 013366

2017-12

V6

Änd.-Nr. 57595