Mediant Anterior Cervical Plating System - Instructions for Use
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician.
MEDIANT™ ANTERIOR CERVICAL PLATING SYSTEM DESCRIPTION
The Mediant™ Anterior Cervical Plating System implants are intended to be used as a construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during anterior cervical fusion procedures (C2-T1), attaching to the spine by means of plates anchored by bone screws. The components of the system are manufactured from Ti-6Al-4V ELI, conforming to ASTM F136.
Implants are provided STERILE. Each implant has been sterilized using gamma irradiation.
Instruments are provided either STERILE or NON-STERILE.
STERILE – Mediant™ Instrument Kit (REF 121220)
Mediant™ Instrument Kit is packaged sterile. Each instrument kit has been sterilized using gamma irradiation. Instruments of the Mediant™ Instrument Kit are sterile if the packaging has not been opened or damaged. Inspect the package before use. Do not use if the packaging has been received opened, torn, punctured, or damaged. Do not use if the seal has been inadvertently broken.
Instruments in the Mediant™ Instrument Kit are for a single procedure use only. DO NOT REUSE. The instruments must be disposed of after use. Do not attempt to sterilize or clean the instruments. Cleaning or reuse may result in improper function of the instruments.
Modification, mishandling or reuse of the instruments will invalidate the calibration of the instrument and may result in improper function of the instrument.
NON-STERILE - Mediant™ Instruments
Instruments for the Mediant™ Anterior Cervical Plating System are also offered Non-Sterile. Non-sterile instruments must be cleaned and sterilized prior to each use. Non-Sterile instruments are packaged in sterilization trays. Non-sterile instruments should be stored in the sterilization trays until cleaned and sterilized. For Cleaning and Sterilization of the Mediant™ Non-Sterile, reusable Instruments see Care and Handling of Reusable Instruments IIS LBL 091614 Rev. B.
The Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation 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, pseudoarthrosis, and failed previous fusion.WARNING
- This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Contraindications include but are not limited to:
- History of recent infection, systemic, spinal, or localized
- Morbid obesity
- Mental illness
- Alcoholism or drug abuse
- Fever or leukocytes
- Metal sensitivity/allergies to implant materials
- Severe osteopenia
- Presence of congenital abnormalities, vague spinal anatomy, tumors, or any other condition which may prevent secure implant screw fixation and/or decrease the useful life of the device.
- Any condition where the device will interfere with anatomical structures or physiological performance, including inadequate tissue coverage over the operational site.
- Patients unwilling or unable to follow post-operative care instructions
Any circumstances not described under INDICATIONS
- The Mediant™ Anterior Cervical Plating System has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The Mediant™ Anterior Cervical Plating System has not been tested for heating or migration in the MR environment.
- No components of the Mediant™ Anterior Cervical Plating System should be used with components from any other system or manufacturer. The Mediant™ delivery instrumentation should be used to implant and connect the devices. The use of any other drivers, taps, or other instrumentation may compromise the integrity of the construct.
- Refer to the Mediant™ Anterior Cervical Plating System Surgical Technique Manual for detailed implantation information. To obtain a Surgical Technique Manual, please contact Intelligent Implant Systems Customer Service Department at (704) 424-1009 or your Sales Representative.
- As with all orthopedic implants, none of the Mediant™ Anterior Cervical Plating System components should ever be reused under any circumstances.
- Based on fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, and other patient conditions, etc. which may impact the performance of the system.
- 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-union. These patients should be advised of this fact and warned of the consequences. Other poor candidates for spine fusion include patients who are obese, malnourished, have poor muscle or bone quality, or nerve paralysis patients.
- Only those patients who meet the criteria of one or more of the indications and did not have conditions included in the CONTRAINDICATIONS should be selected for implantation.
- The implant components should be handled and stored carefully, protected from any damage, including corrosive environments.
- The surgeon must confirm that all necessary implants and instruments are on hand for the planned surgical construct. Components from other manufacturers should not be combined with components from the Mediant™ Anterior Cervical Plating System.
- Prior to use, inspect implant and instrument packaging to ensure there is no damage. If damage is observed, discontinue use and discard following appropriate institutional requirements.
- Extreme caution should be used around the spinal cord and nerve roots, especially when inserting the screws.
- Breakage, slippage, misuse, or mishandling of the instruments or implant components may cause injury to the patient or hospital personnel.
- The implants must be handled carefully to avoid notching or scratching of the surface.
- Before closing the soft tissue, all of the Slide Locks should be locked securely according to the surgical technique.
- Explanted implants must never be reused.
- The surgeon must consider removing the implant after healing, as implants can loosen, fracture, or corrode even after fusion has occurred. The risks and benefits of a second surgery must be carefully evaluated.
- The patient should be instructed in the proper use of external braces or any other weight bearing or assist devices that may be required. In addition, the patient should be instructed to limit those physical activities that would place excessive stresses on the implants or delay the healing process.
- The patient should also be instructed in the proper methods to ambulate, climb stairs, get in and out of bed, and perform activities of daily living, while minimizing the rotational and bending stresses.
POSSIBLE ADVERSE EFFECTS
- Pre-operatively, the patient should be made aware of the possible adverse effects of spinal implant surgery. Additional surgery may be necessary to correct some of these effects.
- Bending, loosening, or fracture of the implants.
- Metal sensitivity to a foreign body, including possible tumor formation.
- Skin or muscle sensitivity in patients with inadequate tissue coverage at the operative site, which may result in skin breakdown and / or wound complications.
- Non-union and delayed union.
- Nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral spinal fluid leakage.
- Pain or discomfort.
- Bone loss due to resorption or stress shielding, or bone fracture above or below the level of surgery.
- Hemorrhage of blood vessels and/or hematomas.
- Malalignment of anatomical structures including loss of proper spinal curvature, correction, reduction, and/or height.
- Bone graft donor site pain.
- Inability to resume activities of normal daily living.
Implants should be handled with care always. Store away from areas of direct sunlight and sources of electro-magnetic radiation. The Sterile Mediant™ Instrument Kits should be handled with care always. Store away from areas of direct sunlight and sources of electro-magnetic radiation.
CAUTION: Do not attempt surgical procedure with faulty, damaged, or suspect implants or instruments. Inspect all components preoperatively to assure utility. Alternative fixation methods should be available intraoperatively.
For further information on the Mediant™ Anterior Cervical Plating System please contact:
Intelligent Implant Systems, LLC
3300 International Airport Drive
Charlotte, NC 28208
Phone: (704) 424-1009
IIS LBL 113017 Rev. A