The Dynam’X System implants are devices whose primary functions are to add a solid structure to a graft so as to enable the stabilization of intervertebral height, after discectomy, during the time of graft setting and achieve a maximum surface of fusion. Various models and sizes of implants are available in order to adopt to the surgical approach, operating level(s) and to the pathology and individual patient anatomy. In addition, so as to favor bone growth, the Dynam’X System Cage should be filled with bone graft.
Dynam’X System is indicated for intervertebral body fusion procedures in skeletally mature patients which have had six months of non-operative therapy. Final decision of the application of the Dynam’X System should be always taken by experienced surgeons with extensive knowlegde about spinal surgey. The intended use is to recreate the intervertebral disc high and give structural support for loading forces during the healing process and support fusion process. The Dynam’X Cages are complementary implants to posterior or anterior or lateral fixation systems and should NOT be used as standalone.
The Dynam’X System is designed for spinal arthrodesis. It consists of the cages in variable sizes and shapes. The main design of the whole family based on the same concept:
System recognizes following models of interbody devices with intended application approach and spine levels:
Model selection depends on physician decision about the way how to approach the treatment of the spinal disorder. The composition of implants may be vary depends on anatomical conditions and physician decision. Products Brochures and Surgical Technigues should be read and analyzed before select suitable implants (includind correct size and model), and its accesories in order to obtain safe combination.
Dynam’X System components must NOT be used with direct contact to any other spinal systems or any other fixation systems. Do NOT never mix titanium implant and stainless steel implant in the same construct. Any application of any components from Dynam’X System together with any other systems or other manufactures releases Syntropiq for any liabilities.
All components of Dynam’X System should be never reused under any circumstances.
The entire system is be made out of medical grade titanium or titanium alloy Ti-6Al-4V ELI described by ISO 5832-3 or ASTM F3001-14 or ASTM F136-13 standards. Syntropiq sorely warrants that all devices are manufacture from one of the foregoing material specifications. No other warranties, express or implied, are made. Please see the Syntropiq product brochure for further information.
Dynam’X System is intended for intervertebral body fusion in cervical, thoracic and lumbar spine for the following indications:
Contraindications include, but are not limited to:
Possible adverse events which might occur after spinal surgery with or without instrumentation include, but are not limited to:
In some of cases additional surgery or surgeries might be necessary to correct or change potential adverse events.
The effectiveness and safety of interbody fixation is only applicable for certain conditions with significant instability which require the fusion supported by medical device. The device might be supportive for such mechanical instability like deformity, fracture, listhesis, dislocation, tumor, pseudoarthrosis. The effectiveness and safety for any other conditions are unknown.
The Dynam’X Cages are complementary implants to posterior or anterior or lateral fixation systems and should NOT be used as standalone. The applications of pedicle screw, plates, rods and/or interbody cages should be performed by experienced surgeons with specific training in use of Dynam’X System.
As the Dynam’X T implants must be used with supplemental fixation, close attention should be paid during the insertion of the anchoring plates, in order to limit risk of contact between the anchoring plates and additional spinal hardware (e.g., pedicle screws).
Being a technically demanding procedure presenting a risk of serious injury to the patient, the implantation of Dynam’X System should be performed only by experienced spine surgeons with specific training in the use of this system and who have knowledge of the present instructions for use. Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the system. This device is recommended for use only by surgeons familiar with preoperative and surgical techniques, cautions and potential risks associated with spinal surgery. Knowledge of surgical techniques, proper implant selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome.
The spinal screw fixation system and/or inter body cage system should not be considered as sole spinal support. No implants can withstand body loads without bone support. Therefore bends, breakages, loosening, disassembling may occur over the time. A successful results are not always achievable. The factors as proper preoperative and operative procedure, comprehensive knowledge of surgical techniques, proper selection of implant’s size and type are considerably important in treatment process. Patients with obesity, smokers, alcohol abused are risk of non-fusion surgery. Also patients in weak muscle or bone conditions, nervous system dysfunctions are poor candidates for spinal fusion. Prior or during or after the surgery in order to evaluate or check the positioning of the implants or patients anatomy or any other patients or implants correction X-ray or CT or any other invasive diagnostic examinations may be necessary to be performed.
The proper, patient’s individual implants selection in terms of type, size, shape or design is vital to successful surgery performance. Proper implants and instruments handling is crucial. Extensive bending or contouring should be avoided. Sharp edges cutting, reversed bending, scratching or notching may generate internal stressing which may weak the implants or construct. In some cases, progression of degenerative disease may be so advanced at the time of implantation that they substantially decrease the expected useful life to the implant. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.
Based on the non-clinical testing has demonstrated the Dynam’X System implant is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Under the scan conditions defined above, the Dynam’X System implants is expected to produce a maximum temperature rise of less than 5°C after 15 minutes of continuous scanning. Prior MRI diagnostic procedure MRI technical staff should be informed about the model of Dynam’X implant(s) and implantation anatomical region(s).
All necessary informations about surgery, potential risks, benefits and adverse effects should be conveyed to the patient prior to surgery.
Prior surgery consult with patient any allergy or other reactions on implants chemical components (specially aluminium, titanium, vanadium).
The physician’s postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely important.
Dynam’X System is delivered as sterile. Each of the implant’s components should be stored in original packages. All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of the device.
Prior to use double check of sterility conditions and expiration date should be performed.
Do not use when sterility expired.
Do not use if packaging is damaged.
Only originally delivered Syntropiq instruments should be used during implantation procedure. Before every surgery all instruments must go under reprocessing procedure described in Syntropiq Tools Instruction for Use or must be cleaned using established hospital methods before sterilization and introduction into a sterile surgical field.
The components of Dynam’X System should be completely dry before storing and must be handled with care to prevent damage. Store in designated trays and in areas which provide protection from dust, insects, chemical vapors and extreme changes in temperature and humidity.
Sterile parts should be stored in original packages and prevented to any damages. When storing please keep the following parameters: relative humidity between 20% and 50%, temperature between 10°C and 35°C.
The implants from Dynam’X System are intended to remain in the patient’s body throughout life. Any decision by a surgeon to remove the device should take into consideration such factors as the risk to the patient of the additional surgical procedure as well as the difficulty of removal. However if medical or non medical reasons require device removal its disposal procedure should be performed in accordance of local hospital’s requirements and protocols.
Implant’s removal procedure can be performed either by the Implant Holder (inserter) or universal Implants Removal Tool in a clockwise rotation to the implant. Universal Implants Removal Tool is available upon special request. Please contact Syntropiq Customer Service prior revision surgery. Be careful to avoid pushing the implant forward. A slap hammer or slotted mallet may be used in conjunction with the Inserter or Removal Tool for removal of the implant if desired. To use, apply an upward force to the slap hammer. Repeat until implant is removed from the intervertebral disc space. An osteotome can be used at the interface between the Implant and endplates to disengage the construct. Use of distraction is suggested to allow easier access to the implant/ endplate interface.
As with all orthopaedic implants, the Dynam’X System components must be never reprocessed nor reused under any circumstances.
Every spinal product from Syntropiq is guaranteed to be free of defects in workmanship and materials when used properly for its intended purpose. Any implant or instrument delivered from Syntropiq proving to be defective will be replaced or repaired, at Syntropiq discretion, with no any charge.
Any customer or user, who has any complaint or who has experienced any dissatisfaction in the product quality, durability, reliability should inform Syntropiq or its Distributor. When filing a complaint please provide the component(s) name, part number, lot number(s), your name and address, the description of the complaint. Please provide the report directly to Syntropiq or to its Distributor.
Syntropiq
Braunerova 563/7
180 00 Prague
Czech Republic phone 00420 770 147 127
www.syntropiq.com
Additional information about the Dynam’X System or any other Spinal Systems is available from Syntropiq. You may also want to contact your local Syntropiq Sales Representative.
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