ulrich medical uCentrum Instructions For Use Manual page 13

Under these scan conditions, the risks to the patient during an examination are low. To minimize heating, the scan time should be as brief as
possible and the SAR should be kept as low as possible.
Artefacts: MR imaging in the area of the implants can be impaired by artefacts. In the experimental test, there were artefacts up to 28 mm
radially around the implant.
The scans were performed with the following parameters:
FFE sequence: TR 100 ms, TE 15 ms, flip angle 30°
SE sequence: TR 500 ms, TE 20 ms, flip angle 70°
The SE sequence demonstrates reduced artefacts (≤ 17 mm).
The attending physician should conduct a careful risk/benefit assessment.
INDICATIONS FOR USE
The uCentum™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion
of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum™ is intended for the
following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient
history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis),
fracture, spinal tumor, pseudarthrosis and failed previous fusion.
CONTRAINDICATIONS
ƒ Patients with acute infection, whether superficial or deep
ƒ Observed bone defects of the anterior spine without additional anterior bridging
ƒ Patients with fever or leukocytosis
ƒ Patients with spine associated infections (e.g. spondylodiscitis)
ƒ Patients with documented material allergy or tendency for reactions to foreign bodies
ƒ Patients with acute superficial and deep infection
ƒ Patients with a poor general medical or psychological condition which could be further exacerbated by the intervention; in these patients
the attending surgeon must carefully weigh the risks and benefits
ƒ Patients with insufficient bone mass or bone quality, e.g. severe osteoporosis, osteopenia, osteomyelitis
ƒ Patients who are pregnant
ƒ Any condition not described in the Indications for Use
WARNINGS AND PRECAUTIONS
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 The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with
poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
ƒ This product is only to be used by a surgeon experienced in spinal surgery.
ƒ Responsibility for the proper selection of patients, adequate training, experience in the choice and placement of implants rests with the
surgeon.
ƒ The patient is to be instructed carefully as to the risks involved in the implantation of the uCentum™ system. The surgeon should discuss the
expectations of surgery inherent in the use of the product with the patient also with respect to the physical limitations of the product. Post-
operative activities influence the duration of the implant and its durability in the bone. The patient must therefore be advised regarding the
risk involved in everyday activities and regarding the appropriate behavior. The physician's instructions are to be strictly obeyed. Particular
attention should be given to a discussion postoperatively and the necessity for periodic medical follow-up.
ƒ Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level,
other patient conditions, etc. which may impact on the performance of the system.
ƒ Selection of the correct implant and its placement is to be observed carefully applying the appropriated radiological technique, before,
during and after surgery. Errors in implant selection and position could result in premature clinical implant failure.
ƒ Failure to use the appropriate product for the application may result in a clinical failure. The implant is to be used in the anatomically cor-
rect position in compliance with currently valid standards for internal fixation. The features and quality of human bone limit the size and
resistance of the implant. Without successful fusion, no implant can resist long term biomechanical forces. Even in the case of complete
bone fusion, bending, breakage or loosening of the implant components can occur.
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.
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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2019-05-06