ulrich medical Obelisc Instructions For Use Manual page 12

APPLICATION
The obelisc Vertebral Body Replacement System (herein referred to as obelisc) is a spinal implant system designed to aid in the treatment of spinal
abnormalities or injuries in the thoracic and lumbar region. Specifically, obelisc implants are used to replace a collapsed, damaged, or unstable
vertebral body, due to tumor or trauma (i.e. fracture). The system is intended to provide stabilization via support of axial compression loads.
The obeliscis available in different expansion heights. It consists of a center piece and corresponding straight or angled end pieces. The straight
or angled end pieces are attached in the required position on the center piece to match the anatomy of the vertebral body being replaced and
accommodate the particular anatomical differences of individual patients.
By means of mechanically rotating a bevel gear unit, the necessary height of the implant can be adjusted. The bevel gear unit is designed to
accept a set screw, which when tightened serves to prevent further movement (distraction) of the obelisc once the desired height has been
achieved.
The use of bone grafting material with the obelisc is optional.
POSSIBLE ADVERSE EFFECTS
In many instances, adverse results may be clinically related rather than implant related.
The potential adverse events associated with use of the obelisc include those adverse events that are associated with non-instrumented spinal
surgery in addition to adverse events that are related specifically to the use of the spinal instrumentation. These adverse events include but
are not necessarily limited to:
ƒ General risks and complications related to surgery.
ƒ Implant migration
ƒ Disassembly, bending, loosening, slippage and/or breakage of any or all of the implant components
ƒ Metal sensitivity or allergic reaction to a foreign body
ƒ Pain, discomfort or abnormal sensations due to the presence of the device
ƒ Loss of proper spinal curvature, correction, height and/or reduction.
ƒ Infection
ƒ Loss of neurological function, appearance of radiculopathy and/or dural tears
ƒ Hemorrhage of blood vessels and/or hematomas.
ƒ Bursitis and/or other types of inflammation
ƒ Deep venous thrombosis, thrombophlebitis and/or pulmonary embolus
ƒ Inability to resume activities of normal daily living
ƒ Death
Note: Additional surgery may be necessary to correct some of these anticipated adverse reactions
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WARNINGS AND PRECAUTIONS
ƒ The following warnings and precautions should be understood by the surgeon and explained to the patient. These warnings are important
considerations particular to metallic internal fixation devices. General surgical risks should also be explained to the patient prior to surgery.
ƒ A successful result is not always achieved in every surgical procedure. In spine surgery, there are many extenuating circumstances, which
may compromise the results. Implants can break when subjected to excessive loading or long term loading associated with delayed union
or non-union. Use of this product without a bone graft and/or supplemental support in such situations may result in a non-union and
device failure.
ƒ The implantation of the obelisc should be performed only by experienced spinal surgeons with special training in the use of this system
because this is a technically demanding procedure presenting a risk of serious injury to the patient
ƒ As with all orthopaedic implants, none of the obelisc components should ever be reused under any circumstances.
ƒ Careful preoperative, intraoperative and postoperative planning is important in the successful utilization of the obelisc by a surgeon. The
use of a C-arm is strongly recommended. In addition, the proper selection and compliance of the patient will greatly affect the results.
ƒ obelisc must be used with supplemental spinal internal fixation systems which have been cleared by FDA for use in the thoracic and lumbar
spine. Such systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.
ƒ Careful handling and storage of the product is required. Scratching or damage to the component can significantly reduce the strength and
fatigue resistance of the product.
ƒ Once applied, the product should never be reused. Although it may appear undamaged, previous stresses may have created imperfections
that could reduce its service life. Only new and undamaged implants may be used. Used or possibly damaged implants must be discarded.
ƒ The patient should be advised to report any unusual changes of the operated site to their surgeon. The patient should be closely monitored
if a change at the fixation site has been detected. The surgeon should evaluate the possibility of subsequent clinical failure, and discuss with
the patient the need for any measures deemed necessary to aid healing.
ƒ Delayed healing, non-union or subsequent bone resorption or trauma may lead to excessive stress on the implant(s) and result in loosening,
bending, cracking or fracturing
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
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2019-09-10