ulrich medical uCentrum Instructions For Use Manual page 14

ƒ The rods should only be bent using the bending instruments in the system intended for this purpose. Bending back and/or repeated con-
touring of straight rods, as well as bending of curved rods is not permitted.
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.
ƒ The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical
instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical stability or deformity of the
thoracic, lumbar and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolis-
thesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.
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. This device system is not intended to be the sole means of spinal support. Implants can break when subjected
to the increased loading associated with delayed or non-union. Use of this product without bone graft or in cases that result in a non-union
will not be successful.
ƒ Careful preoperative, intraoperative and postoperative planning is important in the successful utilization of the system by a surgeon. In
addition, the proper selection and compliance of the patient will greatly affect the results.
ƒ Use uCentum™ components only with other uCentum™ components; do not use with components from any other spinal system or manu-
facturer. As with all orthopedic implants, none of the uCentum™ system components should ever be reused under any circumstances.
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 Implants are single use only. Once the implant has been used, it must not be used again. Even if the implant appears undamaged, previ-
ous strain may have resulted in irregularities that could shorten the implant life. Only new, undamaged implants may be used. Used or
potentially damaged implants must be discarded.
ƒ A prolonged healing phase, unsuccessful bone fusion or subsequent bone resorption or trauma can place undue stress on the implant,
which, in turn, could lead to loosening, deformation, cracks or breakage of the implant.
COMPLICATIONS
In many cases, possible complications are caused by use rather than the implant:
ƒ General risks and complications from the operation
ƒ Wound healing impairment
ƒ Infection
ƒ Cardiovascular complications such as: cardiac arrest, pulmonary heart disease, pulmonary embolism, anemia, blood loss, thrombosis, em-
bolism, coagulation disorder
ƒ Lung complications such as: pneumothorax, hematothorax, chylothorax, pulmonary atelectasis
ƒ Gastrointestinal complications such as: gastritis, stress ulcers, intestinal obstruction, ulcers
ƒ Neurological complications such as: spinal cord lesions or nerve-root lesions with transitory or permanent sensory and/or motor impairments
ƒ Anesthetic risks, blood transfusion risks, positioning damage
ƒ Intraoperative vascular injuries, massive bleeding (hemorrhage)
ƒ Absence of bone fusion and necessity for renewed stabilization
ƒ Implant removal or renewed stabilization due to loosening, dislocation and/or failure of the implant
ƒ Local or systemic reactions due to material intolerances
ƒ Insufficient subjective improvement in symptoms
Special risks and possible complications
ƒ Injury to the nervous structures with temporary or permanent sensory and/or motor damage.
ƒ Injury to the retro-pharyngeal structures caused by excessive perforation of the anterior cortex.
ƒ Impairment of the muscles caused by inappropriate preparation of wound closure.
ƒ Adjacent segment degeneration
USE OF GENUINE PRODUCTS / COMBINATION WITH OTHER SYSTEMS
Unless indicated otherwise system-specific instruments are to be used exclusivlely for the implantation of ulrich medical implants.
Components of ulrich medical system should not be used with components of any other system or manufacturer.
DISPOSAL OF USED MEDICAL DEVICES
Please note the country-specific regulations regarding disposal of hospital waste when disposing of used medical devices.
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.
14
2019-05-06