SPINAL elements


6 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  PIRANHA™ ANTERIOR CERVICAL PLATE SYSTEM IMPLANTS AND INSTRUMENTATION This package insert covers the Piranha™ Anterior Cervical Plate System and Manual Surgical Instruments that are used for the implantation of this system. GENERAL INFORMATION The Spinal Elements Anterior Cervical Plate System consists of cervical plates, bone screws, and a locking shield. All components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The Spinal Elements Anterior Cervical Plate System is intended to provide stabilization of the cervical vertebrae for various indications (see below). The fixation construct is attached to the vertebral body of the cervical spine with bone screws using an anterior approach. Bone screws are available for variable or fixed angle implantation. The Spinal Elements Anterior Cervical Plate System is intended to be removed after solid fusion has occurred. INDICATIONS The Spinal Elements Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2C7) as an adjunct to fusion in the treatment of the following: • Degenerative disc disease (DDD) – defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies • Sponylolisthesis • Spinal Stenosis • Tumors • Trauma (i.e. fracture) CONTRAINDICATIONS The Spinal Elements Anterior Cervical Plate System is not designated or sold for any use except as indicated. DO NOT USE IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION. Contraindications include, but are not limited to: 1. Presence of overt infection and/or localized inflammation or foci or infections. 2. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. 3. Suspected or documented metal allergy or intolerance. 4. Any patient having inadequate tissue coverage over the operative site. 5. Any time implant utilization would interfere with anatomical structures or expedited physiological performance, such as impinging on vital structures. 6. Severe comminuted fractures such that segments may not be maintained in satisfactory proximate reduction. 7. Use in displaced, non-reduced fractures with bone loss. 8. The presence of marked bone absorption or sever metabolic bone disease that could compromise the fixation achieved. 9. Any other medical or surgical condition which would preclude the potential benefit of surgery, such as elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), fever, leukocytosis or a marked left shift in the WBC differential count. 10. The physical contact of the Spinal Elements Anterior Cervical Plate System implants with metal implant made of anything other than implant grade titanium, such as stainless steel (ASTM F899) or other dissimilar metal. 11. Situations with the absence or compromise of significant stabilizing elements. 12. Use in the presence of any neural or vascular deficits or other compromising pathology, which may be further injured by device intervention. WARNINGS Implants and instruments are provided non-sterile. Instruments must be cleaned and sterilized before use. Implants may be processed prior to use and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of. LB-229  Page 1 of 6  Rev. 20201120
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File Name: SPINAL elements - LB-229 - PIRANHA ANTERIOR CERVICAL PLATE System Instructions - 2020-11 - 20201120.pdf

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