ulrich medical Obelisc Instructions For Use Manual page 8

ƒ Lung complications
ƒ Infection
ƒ Wound healing disorders
ƒ Cardiovascular complications, such as blood loss, thrombosis, embolism, coagulopathy
ƒ Gastrointestinal complications, such as gastritis, ileus, ulcer
ƒ Neurological complications, such as spinal cord or neural root lesions with temporary or permanent sensory and/or motor disturbances
(bladder and rectal disorders, sexual dysfunction)
ƒ Intraoperative injury to blood vessels, massive hemorrhage, stroke, cerebral hemorrhage with potential life-threatening consequences
ƒ Injury to organs adjacent to the spine, such as cervical, thoracic and abdominal organs, depending on the region operated on
6 Warnings and precautions
6.1 General
ƒ The user has to ensure that the most current versions of the complete product materials provided as overall documentation of the system
are on hand and considered. These are also available at: www.ifu.ulrichmedical.com. A printed copy may be delivered within 7 days,
upon request.
ƒ This product must be used only by an experienced spine surgeon, under sterile conditions and in an operating room where C-arm is
available.
ƒ The product is delivered non-sterile and must be sterilized before its first use. Instructions for processing can be found in the "Processing
manual implants and instruments" UH 1100, prepared as part of the overall documentation of the system.
ƒ The treating physician is responsible for making the proper selection of patients, and for acquiring the training with the system and
experience required for implant selection and placement. The treating physician is also responsible for determining whether to leave the
implant following surgery or to remove it.
ƒ The product must be carefully handled and stored. Implants with any kind of damage or scratches must not be used, as product stability
and resistance to fatigue may be affected.
ƒ Implants of the corresponding ulrich medical systems must be used exclusively with the system-specific instruments intended for this
purpose, unless otherwise indicated.
ƒ Connecting ulrich medical implants to implant components of other manufacturers is not permitted. A combination with other implants
from ulrich medical is not permitted.
ƒ Given the presence of passive layers, corrosion of metal implants is very minimal. Nevertheless, there may be accelerated material fatigue
and the possibility of a break, as well as increased release of metal components in the body. Corrosion is promoted by the components
made of different metals coming into contact and by damage to the implant's surface. The ability to combine the various metal implants
used in the system has been assured. Direct contact with metal implants from other manufacturers is not allowed.
6.2 Preoperative
ƒ The obelisc system is only intended to absorb axial compression force. Additional stabilizing instrumentation is required to absorb the
other forces (e.g. transverse forces with angled end pieces) and torques.
ƒ Implantation should only be considered when all other treatment options have been carefully weighed and ruled out. A successful implant
is also inferior to the healthy moving element(s) of the spine. On the other hand, an implant may be an efficient replacement of one or
more severely deformed or degenerated moving elements in order to eliminate pain and achieve good load bearing capacity.
ƒ The user must carefully weigh the benefits against the risks when using it in a non-mature spine.
ƒ The risks of the procedure and the use of the implant, including any revisions which may be necessary, should be explained to the patient
in detail.
ƒ The treating physician should conduct with the patient a detailed discussion of the surgical results that may be anticipated, particularly
with regard to potential physical limitations of the implant. The degree of postoperative activity affects the life time of the implant and
the stability of the implant in the bone. Thus, the patient must be informed of the limitations and risks inherent in daily activities and
made aware of special guidelines for movement. Smoking can inhibit fusion and may predispose to an increased rate of pseudoarthrosis.
Patients should be informed about the possible negative effects of smoking on the success of a fusion procedure. The treating physician
must assess whether the patient can understand and follow such instructions. Special attention should be given to postoperative discus-
sion and the need for regular medical monitoring.
ƒ Ensure that suitable pre-, intra- and postoperative diagnostic procedures are performed to evaluate and ensure proper implant selection
and placement. For example, direct contact between the implant and delicate tissues (vessel walls, dura etc.) should be avoided in order
to reduce the risk of injury in the event that revision surgery is necessary.
ƒ Errors in implant selection could result in premature clinical implant failure. The number of segments to be treated must be accurately
determined. The shape and composition of human bones limits the size and durability of the implant.
6.3 Intraoperative
ƒ Vertebral body resection includes the neighboring disks.
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