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QF-10-01-110-ENGL-B
Cabo™ Anterior Cervical Plate System - English Rx Only Caution: Federal Law restricts this device to sale by or on the order of physician Manufacturer: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 Telephone: +1-760-727-8399 Fax: +1-760-727-8809 Complaints: [email protected] Customer Service:[email protected] Website: www.seaspine.com DESCRIPTION The Cabo™ ACP (Anterior Cervical Plate) System implant components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The implantation of the Cabo ACP System is via an anterior surgical approach. The Cabo ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Cabo Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Cabo ACP System implant components are made from titanium alloy such as described by ASTM F136. This material is not compatible with other metal alloys. Do not use any of the Cabo ACP System components with the components from any other system or manufacturer. The manufacturer expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. INDICATIONS FOR USE The Cabo ACP System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. IMPLANT MATERIALS Titanium 6Al-4V ELI per ASTM F136 CONTRAINDICATIONS Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery is a contraindication. The following conditions may reduce the chance of a successful outcome and should be taken into consideration by the surgeon. This list is not exhaustive: ▪ Absolute contraindications: ▪ Infection in or around the operative site ▪ Allergy or sensitivity to implant materials ▪ Any case not described in the indication ▪ Relative contraindications: ▪ Local inflammation ▪ Morbid obesity ▪ Pregnancy ▪ Fever or leukocytosis ▪ Prior fusion at the level(s) to be treated ▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis ▪ Elevation of sedimentation rate unexplained by other diseases, elevation of white blood count
European Representative mdi Europa GmbH Langenhagener Str.71 30855 Hannover-Langenhagen, Germany Telephone: +49 511 39 08 95 30 Fax: +49 511 39 08 95 39 Email: [email protected] Website: www.mdi-europa.com
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(WBC), or a marked left shift in the WBC differential count Any case not requiring bone graft and fusion or where fracture healing is not required Patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition Bone immaturity The patient’s activity level, mental condition, occupation and/or a patient unwilling to cooperate with the postoperative instructions Any case where implant utilization would interfere with anatomical structures or expected physiological performance Use of incompatible materials from other systems
POSSIBLE ADVERSE EVENTS Like other spinal system implants, the following adverse events are possible. This list is not exhaustive: ▪ Delayed union or nonunion (pseudarthrosis) ▪ Bending, disassembly or fracture of implant and components ▪ Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain ▪ Pain, discomfort, or abnormal sensations due to the presence of the device ▪ Pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin. ▪ Dural leak requiring surgical repair. ▪ Cessation of growth of the fused portion of the spine. ▪ Subsidence of the implant into adjacent bone. ▪ Loss of proper spinal curvature, correction, height and/or reduction. ▪ Increased biomechanical stress on adjacent levels. ▪ Improper surgical placement of the implant causing stress shielding of the graft or fusion mass. ▪ Intraoperative fissure, fracture, or perforation of the spine. ▪ Postoperative fracture due to trauma, defects, or poor bone stock. ▪ Serious complications associated with any surgery may occur. These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death. WARNINGS AND PRECAUTIONS This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. The Cabo ACP System is only a temporary implant used for the correction and stabilization of the
Single Use Only
Catalog Number
Lot Number (Batch Code)
Non-Sterile
Authorized Representative in the European Community
Caution, Consult Accompanying Documents
Manufacturer
Product Complies with the Requirements of Directive 93/42/EEC
Product Complies with the Requirements of Directive 93/42/EEC (Class I Devices Only) Consult Instructions for Use www.seaspine.com/eIFU Material
spine. This system is also intended to be used to augment the development of a spinal fusion by providing temporary stabilization. This device system is not intended to be the sole means of spinal support. Bone grafting must be part of the spinal fusion procedure in which the Cabo ACP System is utilized. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. This spinal implant cannot withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will eventually occur. Preoperative planning and operating procedures, including knowledge of surgical techniques, proper reduction, and proper selection and placement of the implant are important considerations in the successful utilization of the Cabo ACP System by the surgeon. Further, the proper selection and compliance of 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 consequence. Obese, malnourished, and/or alcohol and/or other drug abuse patients are also notgood candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also not good candidates for spine fusion. MRI SAFETY The device 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. The safety of the device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. CLEANING AND DECONTAMINATION All instruments that have been previously taken into a sterile surgical field must be decontaminated and cleaned using established hospital methods before sterilization and reintroduction into the sterile surgical field. The following recommendations are for the manual cleaning and decontamination of surgical instruments. These recommendations are considered guidelines with the ultimate responsibility for verifying adequate cleaning remaining with the user. Automated cleaning systems differ between hospitals and therefore must be qualified by the hospital. Manual Cleaning Procedure Step Procedure Remove all gross visible soil with a damp 1 gauze pad or wipe. Prepare an enzymatic cleaning solution 2 (such as Prolystica® 2X Enzymatic) per manufacturer’s instructions. Immerse the instruments in the cleaning solution and actuate all features so the 3 enzymatic cleaner contacts all mated surfaces and soak for 15 minutes. 4 Transfer the instruments to fresh cleaning
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solution (such as Prolystica® 2X Enzymatic). Thoroughly scrub all instruments with a soft bristle cleaning brush while immersed in the enzymatic cleaning solution. Be sure that thorough scrubbing also includes any lumens with an appropriate size brush. Actuate device to allow access to hard to reach areas. Thoroughly rinse all instruments with warm running water and dry with a clean cloth and/or allow to air dry.
Automated Cleaning Procedure Step
1
2
3
Procedure Remove all gross visible soil with a damp gauze pad or wipe. Special attention will be required to examine products with tight crevices, voids, and lumens. Lumens may require pre-cleaning with dampened soft bristle brushes and tight crevices, voids, lumens should be flushed with a syringe. Prepare an enzymatic cleaning solution (such as Prolystica® 2X) per manufacturer’s instructions. Immerse the instruments in the cleaning solution and actuate all features so the enzymatic cleaner contacts all mated surfaces and soak for 15 minutes. Transfer items to a washer and run a cycle with the parameters listed in the following steps.
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PRE-WASH: Cold tap water [2 minutes].
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ENZYME WASH: Enzyme wash using cleaner (such as Prolystica® 2X Enzymatic) per manufacturer’s recommendations, hot tap water [4 minutes].
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DETERGENT WASH: Detergent wash using detergent (such as Prolystica® 2X Alkaline) per manufacturer’s recommendations, hot tap water (66°C/150°F) [2 minutes].
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RINSE 1: Rinse, hot tap water [2 minutes].
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RINSE 2: Purified water rinse (66°C/150°F) [15 seconds]. DRYING: Hot air dry (82°C/180°F) [12 minutes]. Remove items from the washer and remove any residual moisture with a lint free clean cloth.
STERILIZATION The implants, components and instrumentation in the Cabo ACP System are to be sterilized by the hospital prior to surgery. Double wrap trays using FDA-cleared sterilization wraps (2 wraps). The recommended sterilization cycle will provide a Sterility Assurance Level of (SAL 10-6). Following AAMI ST79 guidelines, the validated sterilization cycle for a fully loaded tray is: Method
Steam
Cycle
Pre-vacuum
Temperature and Exposure Time
270°F (132°C) for 4 minutes
Drying Time
20-30 minutes
PACKAGING All packages containing implants should be sealed and intact upon receipt. If the package or product is damaged,
the product should not be used and should be returned. The product must be handled, stored, and opened in such a way that it is protected from inadvertent damage or contamination. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked for damage before use. SURGICAL TECHNIQUE This package insert is designed to assist in using the product and is not intended to provide information on surgical technique. Contact a SeaSpine Representative, [email protected] or +1-760-727-8399 for a Surgical Technique Guide. IMPLANT SELECTION Verify that all parts and necessary instruments are present prior to surgery, including sizes larger and smaller than those that are expected for use. The construct should be assembled prior to surgery. PREOPERATIVE WARNINGS ▪ Only patients that meet the criteria described in the indications should be selected. ▪ Patient condition and/or predispositions such as those described in the contraindications should be avoided. ▪ Care should be used in the handling and storage of the implants. The implants should not be scratched or damaged. Implants and instruments should be protected during storage and from corrosive environments. ▪ All non-sterile parts should be cleaned and sterilized before use. Additional sterile components should be available in case of unexpected need. ▪ Devices should be inspected for damage prior to implantation. ▪ Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient. INTRAOPERATIVE WARNINGS ▪ Consult Surgical Technique Guide for system specific intraoperative warnings, precautions and recommendations. ▪ Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological function. ▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel. ▪ Bone graft must be placed in the area to be fused and the graft must be in contact with viable bone. ▪ Implants and components should not be bent, reshaped, contoured or otherwise modified. ▪ Use great care to ensure that the implant surfaces are not scratched or notched which may reduce the functional strength of the construct. ▪ Avoid excessive torque on screws as this may cause threads to strip and thus a reduction in fixation. ▪ Verify all components of ACP system are properly placed and secured before closing the surgical site. ▪ If the construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened. Failure to do so may cause loosening of the other components.
COMPLAINTS Immediately notify SeaSpine or a SeaSpine representative by phone, fax or email regarding complaints, malfunctions or adverse events associated with this product. When possible, retain the product involved in the complaint and return to SeaSpine as instructed by SeaSpine Customer Service. PRODUCT INFORMATION DISCLOSURE SeaSpine has exercised reasonable care in the selection of materials and the manufacture of these products. SeaSpine warrants to the original purchaser only that each new SeaSpine product is free from manufacturing defects in material and workmanship under normal use and service for a period of six (6) months from the date of delivery by SeaSpine to the original purchaser, but in no event beyond the expiration date stated on any product labeling. SEASPINE DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). Further, this warranty shall not apply to, and SeaSpine shall not be responsible for, any loss arising in connection with the purchase or use of any SeaSpine product that has been repaired by anyone other than an authorized SeaSpine service representative or altered in any way so as, in SeaSpine’s judgment, to affect its stability or reliability, or which has been subject to misuse, negligence or accident, or which has been used otherwise than in accordance with these instructions. IN NO EVENT SHALL SEASPINE BE LIABLE FOR ANY SPECIAL, INCIDENTAL CONSEQUENTIAL, OR CONTINGENT LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM ACQUISITION OR USE OF THIS PRODUCT. SeaSpine neither assumes nor authorizes any person to assume for it any other additional liability or responsibility in connection with this product. SeaSpine intends that this device should be used only by physicians having received proper training in the use of the device.
POSTOPERATIVE WARNINGS ▪ Surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance. ▪ The patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. ▪ The patient should be advised that implants may bend, break or loosen despite restriction in activity. ▪ The patient should be advised to avoid mechanical vibrations that may loosen the device. ▪ The patient should be advised not to smoke or consume alcohol during recovery. Page 2 of 2