Zimmer Biomet Universal Clamp, Руководство по хирургической технике

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Universal Clamp—Surgical Technique Guide 19
Description
The Universal Clamp Spinal Fixation System consists
of a woven band with a stiff guiding section at one end and
metal buckles at the other end, implantable grade metal
clamps that mate with 4.5mm–6.35mm diameter rods and
an implantable grade metal locking screw that tightens the
clamp over the band securing it to the connecting rod.
Implants made from implantable-grade titanium,
implantable-grade titanium alloy and implantable-grade
cobalt chromium may be used together. Due to the risk of
galvanic corrosion, never use titanium, titanium alloy and/or
cobalt chromium with stainless steel in the same construct.
All implants are provided sterile and are single use only; the
implants should not be re-used or re-sterilized under any
circumstances.
The Universal Clamp System implants are fabricated from
materials as shown in the table above.
Indications
The Universal Clamp System is a temporary implant for use
in orthopedic surgery. The system is intended to provide
temporary stabilization as a bone anchor during the
development of solid bony fusion and aid in the repair of
bone fractures. The indications for use include the following
applications:
• Spinal trauma surgery, used in sublaminar or
facet wiring techniques;
• Spinal reconstructive surgery, incorporated into constructs
for the purpose of correction of spinal deformities such
as idiopathic and neuromuscular scoliosis in patients
8 years of age and older, adult scoliosis, kyphosis and
spondylolisthesis;
• Spinal degenerative surgery, as an adjunct to spinal fusions.
The Universal Clamp System may also be used in conjunction
with other medical-grade implants made of similar metals
whenever “wiring” may help secure the attachment of the
other implants.
IMPORTANT INFORMATION ON THE UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
*This device component is not implanted.
Contraindications
The Universal Clamp System is not designed or sold
for any use except as indicated. DO NOT USE THE
UNIVERSAL CLAMP IMPLANTS IN THE PRESENCE OF
ANY CONTRAINDICATION. Contraindications include,
but are not limited to:
• Active systemic infection, or infection localized to the site
of the proposed implantation.
• Severe osteoporosis is a contraindication because it may
prevent adequate fixation.
• Suspected or documented metal allergy or intolerance.
• Inadequate tissue coverage over the operative site.
• In any situation where implant utilization would interfere
with anatomical structures or expected physiological
performance, such as impinging on vital structures.
• Severe fractures such that segments may not be
maintained in satisfactory proximate reduction.
• Any entity or condition that compromises the possibility
of fusion, such as cancer, kidney dialysis or osteopenia.
• Other relative contraindications include obesity,
pregnancy, certain degenerative diseases,
immunosuppressive diseases, major local inflammatory
phenomena and foreign body sensitivity. In addition, the
patient’s occupation or activity level or mental capacity may
be relative contraindications to this surgery. Specifically,
some patients may, because of their occupation or lifestyle,
or because of conditions such as mental illness, alcoholism
or drug abuse, place undue stresses on the implant.
COMPONENT MATERIAL DESCRIPTION STANDARD
4.5mm, 4.75mm and 6.35mm Titanium Alloy Clamp and Locking Screw Ti-6Al-4V ELI ASTM F136
5.5mm and 6.0 mm Titanium Alloy Clamp and Locking Screw
Ti-6Al-4V OR
Ti-6Al-4V ELI
ISO 5832-3 OR
ASTM F136
5.5mm, 6.0mm and 6.35mm Stainless Steel Alloy Clamp
and Locking Screw
Implantable Grade 316L Stainless Steel ISO 5832-1 or ASTM F138
Woven Band (Part of Assembled Band)
Polyester
(Polyethylene-terephthalate—PET)
Not Applicable
Metal Guide* (Part of Assembled Band) Pure Titanium (T40) ISO 5832-2
Metal Buckles* (Part of Assembled Band) Stainless Steel NF EN 10088-1