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INSTRUCTIONS FOR USE DSS™ Stabilization System - Rigid DSS™ Stabilization System - Slotted INSTRUCTIONS FOR USE DSS™ Stabilization System - Rigid DSS™ Stabilization System - Slotted UNITED STATES CONTACT Paradigm Spine LLC 505 Park Avenue, 14th floor New York, NY 10022 USA Phone: (888) 273-9897 Fax: (917) 591-6419 MANUFACTURER Paradigm Spine GmbH Eisenbahnstrasse 84 78573 Wurmlingen / Germany Phone: +49 (7461) 963599-0 Fax: +49 (7461) 963599-20 CAUTION USA Federal law restricts this device to sale by or on the order of a physician. Introduction Like any other temporary internal fixation devices, DSS™ Stabilization System spinal implants have a finite useful life. The patient’s activity level has a significant impact on this useful life. Inform your patient that any activity increases the risk of loosening, bending, or breaking of the implant components. Instruct patients about postoperative activity restrictions and examine patients postoperatively to evaluate the fusion mass development and the implant status. Even if solid bone fusion occurs, implant components may nevertheless bend, break, or loosen. Therefore, tell the patient that implant components may bend, break, or loosen even though restrictions in activity are followed. Because of the limitations imposed by anatomic considerations and modern surgical materials, metallic implants cannot be made to last indefinitely. Their purpose is to provide temporary internal support while the fusion mass is consolidating. These types of implants are more likely to fail if no bone graft is used, if a pseudoarthrosis develops, or if patients have severe or multiple preoperative curves. You may remove these implants after bone fusion occurs. Discuss the possibility of a second surgical procedure with the patient and the risks associated with a second surgical procedure. If the implants do break, consider the patient’s condition and the risks associated with the presence of the broken implant when deciding whether to remove them. Contents The package contains either one DSS™ pedicle screw set, one DSS™ rigid coupler or one DSS™ slotted coupler. See package label for identification. Description Patents Pending in the US and other territories SYMBOLS Manufacturer REF LOT Catalog number Lot number Sterile using irradiation Expiration date (Year-Month) Do not reuse Attention, see instructions for use The DSS™ Stabilization System - Rigid consists of: • DSS™ pedicle screw sets • DSS™ rigid couplers The DSS™ Stabilization System - Slotted consists of: • DSS™ pedicle screw sets • DSS™ slotted couplers All DSS™ implants are supplied sterile and are available in various sizes. The DSS™ pedicle screw set consists of 2 pedicle screws, 2 nuts, 2 spacers and 2 washers. The pedicle screws are cannulated. The nuts, spacers and washers are used to join the pedicle screws to the DSS™ rigid or slotted coupler. The DSS™ pedicle screw set part number is on the labeling. This part number is unique for each set and does not match the part numbers marked on the individual devices. For example, pedicle screw set “DPI5xxyy” consists of: • 2 x DAI06010, DSS™ nut • 2 x DAI06020, DSS™ spacer • 2 x DAI06030, DSS™ washer • 2 x DAI4xxyy, DSS™ pedicle screw “xxyy” is a variable field that is specific for each diameter and length of pedicle screw. The lot number of each device matches the lot number of the set. DSS™ Stabilization System - Rigid The DSS™ rigid coupler consists of two interlocking rods inside one another that are able to translate within a limited range to meet the patient’s anatomy. The rods are locked down with a set screw. The DSS™ rigid coupler is the longitudinal member that increases the segmental stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending, translation and rotation to facilitate fusion. The DSS™ Stabilization System - Rigid is for creating a posterior spinal implant construct and is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. DSS™ Stabilization System - Slotted The DSS™ slotted coupler is cylindrical, includes grooves placed at intervals from the superior to the inferior end of the device, and includes a pedicle screw interface at the superior and inferior end of the device. The length of the DSS™ slotted coupler is adjustable within a limited range by rotating the pedicle screw interface (a 360º rotation changes the length by 0.5 mm until the limit is reached). The DSS™ Stabilization System - Slotted is intended to be used with bone graft for fusion procedures. The Rigid Coupler and Slotted Coupler are not intended to be used together Warnings and precautions Warnings The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5–S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of the DSS™ Stabilization System has not been established for spinal indications beyond those stated in the Indications section. Correct placement of the device is essential to optimal performance. Use of the DSS™ Stabilization System should only be undertaken after the surgeon has become thoroughly knowledgeable about spinal anatomy and biomechanics; has had experience with posterior approach spinal surgeries; and has had hands-on training in the use of this device. The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. The device is only intended to be used when fusion with bone graft is being performed at all instrumented levels. The DSS™ rigid coupler is available in sizes ranging from 22–43 mm, and the DSS™ slotted coupler is available in sizes ranging from 26–40 mm. Pre-operative planning is required to ensure that this size range is appropriate for the patient’s anatomy. The Rigid Coupler and Slotted Coupler are not intended to be used together Precautions All DSS™ implants are made from wrought titanium 6aluminum 4-vanadium alloy (ISO 5832-3). Indications Safety precautions DSS™ Stabilization System - Rigid The DSS™ Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization System - Rigid is intended to be used with autograft and/ or allograft. DSS™ Stabilization System - Slotted The DSS™ Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSS™ Stabilization System - Slotted Coupler is indicated for use in patients: • Who are receiving fusions with autogenous graft only; • Who are having the device fixed or attached to the lumbar or sacral spine; • Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together. Contraindications Do not use the DSS™ implant in cases of: • Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general including conditions that have been shown to be safely and predictably managed without the use of internal fixation devices • Acute or chronic systemic, spinal or localized infections • Active, severe systemic and metabolic diseases • Morbid obesity (BMI>40 or weight more than 100 lbs over ideal body weight) • Pregnancy • Dependency on pharmaceutical drugs, drug abuse, or alcoholism • Lack of patient cooperation • Foreign body sensitivity to the implant material • Degenerative scoliosis greater than 25 degrees • Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or significant osteopenia • Severe osteoporosis as it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system • Patients who may place undue stresses on the implant during bony healing and may be at higher risk for implant failure because of their occupation or lifestyle • Soft tissue deficit not allowing wound closure • Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device • Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae • Bony lumbar spinal stenosis • Pars defect • Clinically compromised vertebral bodies at affected level due to current or past trauma 09/07 Adverse reactions may include: • Nonunion, delayed union • Implant bending or fracture • Implant loosening • Screw back-out, possibly leading to esophageal erosion, implant loosening, and/or reoperation for device removal. • Clinical failure (i.e. pain or injury) due to bending, loosening, wear and tear, fracture of implant, loss of fixation, dislocation and/or migration • Pain, discomfort and/or abnormal sensations due to the presence of the implant • Degenerative changes or instability in segments adjacent to fused vertebral levels • Decrease in bone density due to stress shielding • Primary and/or secondary infections • Metal sensitivity or allergic reactions to implant material • Neurological injury due to surgical trauma or device presence. Neurological difficulties including radicular pain, tethering of nerves in scar tissue, muscle weakness, and paresthesia. • Vertebrae fracture or fracture of bony structures • Injury to vessels, nerves and organs. Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could erode these vessels and cause catastrophic bleeding. • Bursitis • Hematoma and/or impaired wound healing; hemorrhage • Venous thrombosis, lung embolism, and cardiac arrest • Esophageal perforation, erosion or irritation • Damage to lymphatic vessels and/or lymphatic fluid exudation • Dural tears during surgery could result in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis • Spinal cord impingement or damage • Paralysis •Death Only experienced spinal surgeons should perform the implantation of pedicle screw spinal systems with specific training in the use of the DSS™ Stabilization System Rigid and DSS™ Stabilization System - Slotted. This is due to the technically demanding procedure presenting a risk of serious injury to the patient. This system should only be used with instrumentation specifically designed for this system. The DSS™ Stabilization System - Rigid and DSS™ Stabilization System - Slotted are intended to be used with bone graft which is required to provide additional spinal support and facilitate fusion. A successful result is not always achieved in every surgical case. Material LBL 0554 Adverse reactions • Prior to use, thoroughly read these instructions for use and become familiar with the surgical technique. • Keep the instructions for use accessible to all staff. The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques. Proper surgical performance of the implantation is the responsibility of the operating surgeon. • The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrect operating techniques, the limitations of treatment methods or inadequate asepsis. • Under no circumstances may modular implant components from different suppliers be combined. • Each patient’s record shall document the implant used (name, article number, lot number). • During the postoperative phase, in addition to mobility and muscle training, it is of particular importance that the physician keeps the patient well informed about post-surgical behavioral requirements. • Damage to the weight-bearing structures can give rise to loosening, dislocation and migration, as well as other complications. To ensure the earliest possible detection of such catalysts of implant dysfunction, the implant must be checked periodically post operative using appropriate techniques. • Never reuse an implant. Although the implant may appear undamaged, previous stresses may have created non-visible damage that could result in implant failure. • Never use implants if the packaging is damaged. An implant with damaged packaging might be damaged itself and thus may not be used. • Never use implants that are past their expiration date. • Do not resterilize implants. The safety and effectiveness of this device has not been established in patients with the following conditions: • Prior fusion surgery at any vertebral level • Facet joint disease or degeneration • Back or leg pain of unknown etiology • Paget’s disease, osteomalacia, or other metabolic bone disease • Morbid obesity (BMI >40 or weight more than 100 lbs over ideal body weight) • Pregnancy • Taking medications known to potentially interfere with bone/soft tissue healing (e.g., steroids) • Rheumatoid arthritis or other autoimmune disease • Systemic disease including AIDS, HIV, Hepatitis • Active malignancy. Storage, inspection and sterilization The DSS™ implants are packed in protective packaging that is labeled according to its contents. The implants are sterilized with gamma sterilization (25 kGy minimum). • Always store the implant in the original protective packaging. • Do not remove the implant from the packaging until immediately before use. • Store the implant in a dry and dust-free place (standard hospital environment). Disinfection / cleaning The DSS™ implants are not designed to be disinfected or cleaned by the user. Resterilization The DSS™ implants are not designed to be resterilized by the user. Procedure The DSS™ implants must be implanted only with the applicable DSS™ instruments. The DSS™ instruments are available from the manufacturer. Preoperative The operating surgeon draws up an operation plan specifying and documenting the following: • Implant components and their dimensions. • Proper position of the implant components. • Determination of intraoperative orientation points. The following conditions must be fulfilled prior to application: • All required implant component(s) are readily available. • Highly aseptic operating conditions are present. • All requisite implantation instruments must be available and in working order. WARNING: Never use or process damaged or defective instruments. Contact your local representative or dealer for repair or replacement. WARNING: The use of an instrument for tasks other than those for which they are intended may result in damaged / broken instruments or patient injury. • The operating surgeon and operating room team must be thoroughly familiar with the operating technique, as well as the range of implants and instruments to be applied. Complete information on these subjects must be readily available at the workplace. • The operating surgeon must be especially trained in spinal surgery, biomechanical principles of the spine and the relevant operating techniques. The operating procedure must be explained to the patient, and the patient’s understanding of the following information must be documented: • The patient is aware of the risks associated with neurosurgery, general surgery, orthopedic surgery and with general anesthesia. • The patient has been informed about the advantages and disadvantages of the implant procedure and about possible alternative treatments. • The implant can fail due to excessive load, wear and tear, or infection. • The service life of the implant is determined by body weight and physical activity. The implant must not be subjected to overload through extreme strain, or through work-related or athletic activities. • Corrective surgery may be necessary if the implant fails. • The patient must have their physician carry out followup examinations of the implant at regular intervals. Intraoperative DSS™ Stabilization System - Rigid & DSS™ Stabilization System - Slotted Prior to use, verify the integrity of the sterile packaging and check the product expiration date. WARNING: Never use implants if the packaging is damaged. Never use implants that are past their expiration date. Prepare the surgical site for implant introduction. Numerous instruments (e.g., trocar, awl, pedicle finder, reamer, tap and pedicle probe) are provided to prepare the pedicles prior to screw insertion. Introduce the pedicle screws into the pedicles of the affected motion segment using the pedicle screw inserter (note: the pedicle screws are cannulated and may be used with standard 1.6 mm Kwires). Attach the pedicle screw extension rods to the pedicle screws (after removing K-wires, if applicable). Measure the distance between the pedicle screws using the caliper set, and select the applicable size coupler based on the measured distance. DSS™ Stabilization System - Rigid Apply the rigid coupler to the pedicle screws. Add a spacer using the spacer inserter, then a washer and then a nut using the nut driver to each pedicle screw. Use a distraction and/ or compression instrument to achieve sagittal alignment. Once aligned, use the hex driver to “lock” the rigid coupler. Fix the rigid coupler to the pedicle screws by tightening the nuts. A counter torque instrument shall be utilized to avoid movement of the pedicle screws. If desired, the tightening of the nuts may be done prior to “locking” the rigid coupler. Again, the proper tightening torque is reached when the upper half of the nut breaks off. Bone graft shall be used to facilitate fusion. DSS™ Stabilization System - Slotted Adjust the slotted coupler to the measured distance using the coupler length adjuster. Do not apply excessive force when adjusting the slotted coupler length. The slotted coupler has built in stops that limit the minimum and maximum adjustment range. For single level stabilization with the slotted coupler, apply the slotted coupler to the pedicle screws in the orientation as indicated on the implant (the cranial direction is marked with UP and an arrow on the slotted coupler). The coupler pusher may be used to firmly seat the slotted coupler onto the pedicle screws. Add a spacer using the spacer inserter, then a washer and then a nut using the nut driver to each pedicle screw (note: alternative configurations may be used by the surgeon in order to optimize the fit to the anatomy such as screw, washer, spacer, slotted coupler, nut). Fix the slotted coupler to the pedicle screws by tightening the nuts utilizing a counter torque instrument to avoid bending of the slotted coupler and movement of the pedicle screws during tightening. If desired, remove the extension rods with the extension rod remover prior to applying the counter torque instrument. The proper tightening torque is reached when the upper half of the nut breaks off. The slots of the slotted coupler shall remain parallel during tightening (note: if the slots of the slotted coupler are not parallel, correct the coupler position using a counter torque instrument). Remove all instruments. For multi-level cases, only the pedicle screws at both ends of the instrumentation receive a washer. The screws in between receive a first coupler, a spacer, a second coupler and the nut. Any additional washers contained in the blister package shall be disposed. Other than this, the proper technique is applicable as described above for device placement. Bone graft shall be used to facilitate fusion. Postoperative • Reiterate preoperative instructions to the patient. • Ensure that the patient is aware of physical activity restrictions and possible adverse reactions. Revision surgery / implant removal The DSS™ implants are intended for permanent implantation and are not intended for removal. However, removal may be advisable in the following situations: • Implant breakage • Pain due to the implant • Infection • After the development of a solid fusion mass in patients where this is so desired Warranty All warranty rights are lost if repairs or modifications are carried out by an unauthorized service center. The manufacturer does not take responsibility for any effects on safety, reliability or performance of the product if the product is not used in conformity with the instructions for use. Technical alterations reserved. For further information Please contact Paradigm Spine or your authorized representative if further information on this product is needed. Important note This ‘Instructions for Use’ is complete on the date of printing. In the future, additional components of the DSS™ Stabilization System - Rigid and/or DSS™ Stabilization System - Slotted may be added. If using a new component of the DSS™ Stabilization System that is not described in this document, refer to the ‘Instructions for Use’ packaged with that device.