ulrich medical uCentrum Instructions For Use Manual page 9

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 When selecting the screw type, it should be noted that the polyaxial screws are distinguished by the flexibility of the degrees of freedom
on the screw head. Monoaxial screws, by contrast, are superior to polyaxial screws with regard to mechanical stability.
ƒ uCentum should only be used for bilateral instrumentation.
ƒ uCentum pedicle screws are appropriate for implantation in the thoracic, lumbar and sacral vertebrae (T1-S1). Pedicle screws may only be
implanted in S1 in a convergent manner.
ƒ The rods should only be bent using the bending instruments in the system intended for this purpose. Bending back and/or repeated
contouring of straight rods, as well as bending of curved rods, is not permitted.
ƒ The CS 3812-01-015, -030 and -060 offset connectors should only be used in the following manner: not at the end of a pure uCentum instru-
mentation and, when uCentum is placed in the S1 segment, they must be inserted exclusively combined with an iliosacral screw from uBase.
ƒ After insertion, the implant must not be reused and must be disposed of. Even if the exterior of the implant appears unchanged, prior
stress may have caused damage that can lead to implant failure.
6.4 Postoperative
ƒ The patient should be instructed to inform his or her treating physician immediately regarding any unusual changes in the area where
the surgery was performed.
ƒ The patient should be monitored for any changes to the implant area. The treating physician should assess the potential for clinical
implant failure and discuss with the patient the necessary measures to promote further healing.
ƒ The implant serves to promote internal fixation and stabilization of the surgical area over a maximum two-year healing process. The
implants serve no functional purpose after the spine has fused. Implant removal is generally feasible, but should only be performed after
a meticulous risk to benefit assessment by a medical specialist.
ƒ One or more of the following complications may occur, should the implant not be removed after its intended use or after a prolonged
healing phase (no fusion within 2 years):
1. Corrosion, with local tissue inflammation or pain
2. Implant migration, possibly leading to injuries
3. Risk of additional injuries, caused by post-surgical trauma
4. Deflections, loosening or breaks, making removal difficult or impossible
5. Pain, symptoms or unusual sensitivity due to the presence of the implant
6. Risk of infection or inflammation
7. Bone loss due to stress shielding
8. Potential, unknown or unexpected long-term effects
ƒ After implantation, the occurrence of bone resorption and trauma may excessively strain the implant, thus leading to implant failure.
ƒ Implant removal should be followed by appropriate postoperative care in order to avoid fractures or other complications.
ƒ Explanted implants must not be reused.
ƒ The patient should be informed about the necessary behavior after the implantation procedure, including measures to be taken in case of
an event involving the implant. An implant card should be given to the patient.
7 Recommended application
Further description of the uCentum application is included in the surgical technique, prepared as part of the overall documentation of the
system. It is also available at www.ifu.ulrichmedical.com.
8 Material Information
The uCentum implants are manufactured from a titanium alloy according to ISO 5832-3 and ASTM F136. Made of CoCr according to ISO 5832-12
and ASTM F1537: CS 3812-400 Rod, CoCr, Ø 6.0 mm, straight, length 400 mm, hex end, standard approach.
The devices are biocompatible, corrosion-resistant and non-toxic in the intended use as per EN ISO 10993-1.
9 MRI Information
MR
ulrich medical uCentum implants are classified as "MR Conditional" according to ASTM standard F2503.
The "MR Conditional" components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a uCentum
implant can undergo an MRI examination under the following circumstances:
ƒ field strengths of 1.5 T and 3.0 T
ƒ highest field gradient of 30 T/m (3000 G/cm) or less
ƒ maximum specific absorption rate (SAR) of 2 W/kg for normal operating mode
ƒ at 1.5 T: Distance from outer edge of implant to the iso-center of the MRI device > 20 cm AND scan time of a maximum of 30 min
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