20
Universal Clamp—Surgical Technique Guide
Warnings and Precautions
The following are specific warnings, precautions and adverse
effects associated with use of the Universal Clamp System
that should be understood by the surgeon and explained to
the patients. General surgical risk should be explained to the
patients prior to surgery.
•
Implantation should be performed only by experienced
spinal surgeons.
•
All implants are intended for single use only. Single-use
devices should never be re-used or re-sterilized. Possible
risks associated with re-use of or re-sterilization of
single-use devices include:
• Mechanical malfunction
• Transmission of infectious agents
•
Metal sensitivity has been reported following exposure
to orthopedic implants. The most common metals
associated with metal sensitivities (nickel, cobalt and
chromium) are present in medical-grade stainless steel
and cobalt-chrome alloys.
•
After solid fusion occurs, this device serves no functional
purpose and may be removed. In most cases, removal
is indicated because the implant is not intended to
transfer or support forces developed during normal
activities after several months. Any decision to remove
the device must be made by the physician and the
patient, taking into consideration the patient’s general
medical condition and the potential risk to the patient of
a second surgical procedure.
•
Implants can break when subjected to the prolonged
loading associated with delayed union or non-union.
Internal fixation systems are load-sharing devices that
are used to obtain alignment until normal healing
occurs. If healing is delayed or does not occur, the
implant may eventually fail. The degree or success of
union, loads produced by weight bearing and activity
levels will, among other conditions, dictate the longevity
of the implant. Patients should be fully informed of the
risks of implant failure.
•
Universal precautions should be observed by all end
users that work with contaminated or potentially
contaminated medical devices. Caution should be
exercised when handling devices with sharp points
or cutting edges to prevent injuries during and after
surgical procedures and reprocessing.
Additional preoperative, intraoperative
and postoperative warnings and precautions:
Preoperative
•
Never use titanium, titanium alloy and/or cobalt
chromium with stainless steel in the same implant
construct; otherwise, galvanic corrosion may occur.
Intraoperative
•
Insertion of an implant must be done using the
instruments designed and supplied for this purpose
and the technique specific to each device. The details
of this insertion are found in the Universal Clamp System
Surgical Technique supplied by Zimmer Biomet Spine.
•
Bone integrity should be verified. Osteoporosis or any
other bone tissue diseases that may alter the mechanical
properties of the vertebrae must be taken into account
when deciding whether to insert a Zimmer Biomet Spine
Universal Clamp System.
•
Elevators and Band Passers should not be used for
sublaminar passage. They should only be used for
passage around the transverse process.
•
Be sure to follow the markings on the reduction
instrument. Going beyond the markings and forced use
may result in excessive tension and, depending on bone
quality, bony fracture.
•
Be sure to insert the band in the right direction in
the Universal Clamp implant clamp, as indicated by
an arrow engraved on the upper jaw of the clamp.
•
Be sure to follow the instructions for preparing the
loop. The woven band that makes up the loop is
attached using the metal buckles, as described
in the Surgical Technique.
•
Be sure to place the Universal Clamp implant properly
on compatible rod by verifying that the arrow engraved
on the clamp is visible and pointing toward the mid-line
of the spinal column.
•
Be sure not to over tighten the Universal Clamp
implant’s locking screw prior to performing reduction
or compression/distraction maneuvers. Over tightening
reduces compression/detraction capabilities and
increases the risk of damage to the band. Two tightening
turns are sufficient prior to compression/distraction.
•
Be sure not to over tighten the locking screw using
the locking screw holder. The end of the locking screw
holder may cause damage to the imprint of the locking
screw head.
•
Be sure to avoid any risks of sepsis related to the band.
Bands may be placed in sterile plastic bags bilaterally
along the incision.
•
Be sure to firmly tighten the Universal Clamp implant
locking screw. Only use the final screwdriver for final
tightening, as this driver is not tapered at the tip.
•
Ensure final screwdriver is axially aligned with the
Universal Clamp locking screw during final tightening
of the implant.
