Gold standard orthopaedics, llc

502001
Rev E 04-29-13
Gold Standard Orthopaedics, LLC
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 as described in the INDICATIONS Section. The safety and effectiveness of this device for any other conditions are unknown. These implants are not permanent prostheses. In the absence of fusion, the instrumentation and/or Important Information Concerning the GSO GS1 Spinal System
one or more of its components can be expected to bend, loosen, disassemble and/or break as a result of exposure to everyday mechanical stresses. Caution: FEDERAL LAW (USA) RESTRICTS THESE
DEVICES TO SALE BY OR ON THE ORDER OF A
In all cases, instrumentation must be at least 1cm from any major vessel. PHYSICIAN.
PRECAUTIONS: The implantation of pedicle screw spinal systems should be performed only by
experienced spinal surgeons with specific training in their use because this is a technically
PURPOSE: The purpose of the GSO GS1 Spinal System is to assist in providing immobilization
demanding procedure presenting a risk of serious injury to the patient. Preoperative planning of and stabilization of spinal segments as an adjunct to the fusion of the thoracic, lumbar and/or sacral spinal device system constructs able to withstand trauma or deformity induced body load concentrations is an important consideration for achieving bony fusion and successful surgical outcomes. The surgeon is responsible for preoperative planning, familiarity with operative DESCRIPTION: The GSO GS1 Spinal System consists of rods, non-cannulated and cannulated
techniques and ancillary instrumentation, and preoperative consultation with experienced screws, hooks and adjustable crosslink components that can be locked rigidly into various associates to achieve successful post surgical results. A successful result is not always achieved in configurations, with each construct being customized for each individual case. The implants are every surgical case. This fact is especially true in spinal surgery where many extenuating attached to the spine posteriorly by means of screws and/or hooks joined with rods. Crosslink circumstances may compromise the results. This device system is not intended to be the sole components are used to attach two rods in parallel. GSO implants can be installed with any means of spinal support. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will The GSO Spinal System Implant components are fabricated from medical grade titanium and/or titanium alloy. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for specific purposes or use are explicitly excluded. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy successful utilization of the system by the surgeon. Further, the proper selection and compliance of components with stainless steel components in the same construct. the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this Do not use, reuse, or combine any of the GSO Spinal System Implant components with consequence. Obese, malnourished and/or alcohol abuse patients are also poor candidates for spine components from any other manufacturer under any circumstances unless expressly allowed to do fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates INDICATIONS: The GSO GS1 Spinal System is intended to provide immobilization and
Physician Note: Although the physician is the learned intermediary between the company and the stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended patient, the important medical information given in this document should be conveyed to the to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion. POTENTIAL ADVERSE EVENTS: All of the possible adverse events associated with spinal
As a pedicle screw system, using either non-cannulated or cannulated screws, the GSO GS1 Spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth adverse events includes, but is not limited to: lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the Early or late loosening of any or all of the components. lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. Post-operative change in spinal curvature, loss of correction, height and/or reduction. In addition, when used as a pedicle screw system, the GSO GS1 Spinal System is indicated for the Disassembly, bending and/or breakage of any or all of the components. treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and Urinary retention or loss of bladder control or other types of urological system sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Non-union (or pseudarthrosis). Delayed union. Mal-union. Foreign body (allergic) reaction to implants, debris and corrosion of products (from When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system the GSO crevice, fretting and/or general corrosion), including metallosis, staining, tumor Degenerative disc disease (as defined by chronic back pain of discogenic origin with Dural tears, pseudomeningocele, fistula, persistent CSF leakage and meningitis. degeneration of the disc confirmed by history and radiographic studies) Loss of neurological function (e.g. sensory and/or motor) including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy and/or the development or continuation of pain, Paralytic scoliosis and/or pelvic obliquity numbness, neuroma, spasms, sensory loss, tingling sensation and/or visual deficits. Pressure on the skin from component parts in patients with inadequate tissue coverage Neuromuscular scoliosis associated with pelvic obliquity over the implant possibly causing skin penetration, irritation, fibrosis, neurosis and/or pain and bursitis. Tissue or nerve damage caused by improper positioning or Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, irritation, arachnoiditis and/or muscle loss. Fracture, microfracture, resorption, damage or penetration of any spinal bone Unsuccessful previous attempts at spinal fusion (including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above and/or below the level of surgery. Retropulsed graft. For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment Herniated nucleus pulposus, disc disruption or degeneration at, above or below the only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only. Cessation of any potential growth of the operated portion of the spine. CONTRAINDICATIONS: Contraindications include, but are not limited to:
Development of respiratory problems, e.g. pulmonary embolism, atelectasis, Active infectious process or significant risk of infection (immunocompromise). Loss of increase in spinal mobility or function. Any patient with bone absorption, osteopenia, osteomalacia and/or osteoporosis. Inability to perform the activities of daily living. Any case not requiring bone graft and fusion. Scar formation possibly causing neurological compromise or compression around Any case where the components would be too large or too small to achieve a Bone loss or decrease in bone density, possibly caused by stress shielding. Graft donor site complications, including pain, fracture or wound healing problems. Ileus, gastritis, bowel obstruction or loss of bowel control or other types of Any pathological condition that would preclude the potential benefit of spinal implant surgery such as presence of congenital abnormalities, elevation of sedimentation rate Hemorrhage, hematoma, vascular occlusion, seroma, edema, hypertension, embolism, unexplained by other diseases, elevation of white blood cell count or a marked left stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to shift in the WBC differential count.; elevation of sedimentation rate unexplained by blood vessels, or other types of cardiovascular system compromise. other disease or elevation of white blood cell count or a marked left shift in the WBC Reproductive system compromise, including sterility, loss of consortium or sexual Any patient with inadequate soft tissue coverage of operative site or inadequate bone Any patient with allergy or intolerance of the implant materials. Note: Additional surgery may be necessary to correct some of these potential adverse events.
Any patient in whom utilization would interfere with anatomical structure or Other preoperative, intraoperative and postoperative warnings and precautions:
Any patient unwilling to follow post operative instructions. IMPLANT SELECTION: The selection of the proper size, shape and design of the implant for
union persists or if the components loosen, bend and/or break, the device(s) should be each patient is crucial to the success of the procedure. Metallic surgical implants are subject to revised and/or removed immediately before serious injury occurs. The patient must repeated stresses in use, and their strength is limited by the need to adapt the design to the size and be adequately warned of these hazards and closely supervised to ensure cooperation shape of the human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may The GSO GS1 Spinal System implants are temporary internal fixation devices. cause metal fatigue and consequent breakage, bending or loosening of the device before the healing Internal fixation devices are designed to stabilize the operative site during the normal process is complete, that may result in further injury or the need to remove the device permanently. healing process. After the spine is fused, these devices serve no functional purpose and should be removed. The implants are not intended to transfer or support forces DEVICE FIXATION:
developed during normal activities. If the device is not removed following When tightening the set screws, always hold the assembly with the Counter Torque device. completion of its intended use, one or more of the following complications may occur: Tighten the head of the set screw to at least 80 to 100 in-lbs. to leave the assembly at optimum Corrosion, with localized tissue reaction or pain; Migration of implant position, possibly resulting in injury; Risk of additional injury from postoperative trauma; Bending, loosening and/or breakage, that could make removal impractical or difficult; PREOPERATIVE:
Pain, discomfort, or abnormal sensations due to the presence of the devices; Possible Only patients that meet the criteria described in the indications should be selected. increased risk of infection; Bone loss due to stress shielding; and Potential unknown All instruments should be cleaned and sterilized before use. Implants, if not provided and/or unexpected long term effects such as carcinogenesis. Implant removal should sterile, must be sterilized before use. Additional sterile components should be be followed by adequate postoperative management to avoid fracture, re-fracture or Care should be used in the handling and storage of the implant components. The Any retrieved devices should be treated in such a manner that reuse in another surgical implants should not be scratched or otherwise damaged. Implants and instruments procedure is not possible. As with all orthopaedic implants, the GSO GS1 Spinal should be protected during storage, especially from corrosive environments. System components should never be reused under any circumstances. Patient conditions and/or pre-dispositions such as those addressed in the aforementioned contraindications should be avoided. MRI: The GSO GS1 Spinal System has not been evaluated for safety and compatibility in the MR
An adequate inventory of implants should be available at the time of the surgery, environment. The GSO GS1 Spinal System has not been tested for heating or migration in the MR normally a quantity in excess of what is expected to be used. Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the devices to PACKAGING: Packages for each of the components should be intact upon receipt. If a loaner or
verify that all parts and necessary instruments are present before the surgery begins. consignment system is used, all sets should be carefully checked for completeness and all The GSO GS1 Spinal System implants (described in the DESCRIPTION Section) are components including instruments should be carefully checked to ensure that there is no damage not to be combined with the implants from another manufacturer. prior to use. Damaged packages or products should not be used, and should be returned to the INTRAOPERATIVE:
Extreme caution should be used around the spinal cord and nerve roots. Damage to CLEANING AND DECONTAMINATION: Implants are supplied clean in sealed packaging.
the nerves will cause loss of neurological function. Utilize an imaging system to facilitate surgery. For surgical instruments refer to Important Information Concerning GSO Surgical Instruments for Breakage, slippage or misuse of instruments or implant components may cause injury instrument cleaning and care instructions. Bone graft must be placed in the area to be fused and graft material must extend from Note: Certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or the upper to the lower vertebrae being fused. other alkaline cleaners may damage some devices. These solutions should not be used. All The rods should not be repeatedly or excessively bent. The rods should not be reverse products should be treated with care. Improper use or handling may lead to damage and/or bent in the same location. Use great care to insure that the implant surfaces are not possible improper functioning of the device. scratched or notched, since such actions may reduce the functional strength of the construct. If the rods are cut to length, they should be cut in such a way to create a STERILIZATION: Unless marked sterile and clearly labeled as such in an unopened sterile
flat, non-sharp surface perpendicular to the midline of the rod. Cut the rod outside of package provided by the company, all implants and instruments used in surgery must be sterilized the operative field. Whenever possible, use pre-cut rods of the length needed. by the hospital prior to use. Remove all packaging materials prior to sterilization. Instrument When tapping a Cannulated screw, a Guide-wire should first be used. Caution: Be cases do not provide a sterile barrier and must be used in conjunction with an FDA cleared, intact careful that the Guide-wire is not inserted too deep, becomes bent, and/or breaks. steam sterilization compatible wrap to maintain sterility. When properly positioned, as confirmed by x-rays, the Guide-wire should be followed Only sterile products should be placed in the operative field. Unless specified otherwise, these products are recommended to be steam sterilized by the hospital using the following process Caution: Ensure that the Guide-wire does not advance during tapping or screw Caution: Do not over-tap or use a screw that is either too long or too large. Over Temperature*
Exposure Time*
Drying Time*
tapping or using an incorrectly sized screw may cause nerve damage, hemorrhage or other possible adverse events listed elsewhere in the package insert. If screws are *Note: Because of the many variables involved in sterilization, each medical facility should being inserted into spinal pedicles, use as large a screw diameter that will fit into each calibrate and verify the sterilization process (e.g. temperatures, times) used for the equipment. For outside of the United States, some non-U.S. Health Care Authorities recommend sterilization To assure maximum stability, two or more crosslinks on two bilaterally placed, according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt- continuous rods, should be used whenever possible. Jakob disease, especially of surgical instruments that could come into contact with the central Before closing the soft tissues, provisionally tighten (finger tighten) all of the nuts or screws. Once this is completed, go back and firmly tighten all of the screws and nuts. Recheck the tightness of all the nuts or screws. After finishing, ensure that none loosened during the tightening of the other nuts and screws. Failure to do so may PRODUCT COMPLAINTS: Any Health Care Professional (e.g. customer or user of this system
cause loosening of the other components. of products) who has any complaints or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify the POSTOPERATIVE: The physician’s postoperative directions and warnings to the patient, and the
Gold Standard Orthopaedics distributor. Further, if any spinal system component ever corresponding patient compliance, are extremely important. malfunctions (i.e. does not meet any of its performance specifications or otherwise does not Detailed instructions on the use and limitations of the device should be given to the perform as intended), or is suspected of doing so, the distributor should be notified immediately. If patient. If partial weight-bearing is recommended or required prior to firm bony any Gold Standard Orthopaedics product ever malfunctions and may have caused or contributed to union, the patient must be warned that bending, loosening and/or breakage of the the death or serious injury of a patient, the distributor should be notified immediately by telephone, device(s) are complications that may occur as a result of excessive or early weight- FAX or written correspondence. When filing a complaint, please provide the component(s) name bearing or muscular activity. The risk of bending, loosening or breakage of a and number, lot number(s), your name and address, the nature of the complaint and notification of temporary internal fixation device during postoperative rehabilitation may be whether a written report from the distributor is requested. increased if the patient is active, or if the patient is debilitated or demented. The patient should be warned to avoid falls or sudden jolts in spinal position. FURTHER INFORMATION: If further details for the use of this system are needed, please
To allow the maximum chances for a successful surgical result, the patient or devices check with the Gold Standard Orthopaedics distributor. If further information is needed or should not be exposed to mechanical vibrations or shock that may loosen the device required, please see the address on this document. construct. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sports participation. The patient should be advised not to smoke tobacco or utilize nicotine products or to consume alcohol or non-steroidals or anti-inflammatory medications such as aspirin and other COX-1 and COX-2 inhibitors and Ketorolac Promethamine during the bone graft healing process. As a precaution before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic antibiotics may be considered, especially for high 2007 Gold Standard Orthopaedics. All rights reserved. The patient should be advised of his or her inability to bend or rotate at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause the eventual bending, loosening or breakage of the device(s). It is important that the immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. If a state of non-

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