Usa - ulrich medical uCentrum Instructions For Use Manual

SYSTEM:
COUNTRY:
!
Rx only
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MANUFACTURER:
ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm | Germany
GENERAL INFORMATION
Please ensure that you are using and observing the most current instructions for use and surgical technique of this system at all times.
These can be downloaded any time free of charge at: www.ifu.ulrichmedical.com
A printed copy will be provided upon request.
DESCRIPTION
uCentum™ comprehensive posterior system is used to provide stabilization, fixation and correction of the thoracic and lumbar regions of the
spine, including the sacrum if necessary. The system components include rods, polyaxial screws and a rod-to-rod crosslink. These implant
components can be assembled in a variety of configurations such that treat each construct may be tailored to the individual case.
uCentum™ pedicle screws are available cannulated and non-cannulated. The cannulated screws can be used with guide wires. Final tightening
of the screw eliminates the polyaxial function and provides rigid stability. However, by loosening the locking screw, the surgeon can regain
the polyaxial ability.
Pedicle screws may only be implanted in S1 in a convergent fashion.
Notice: The implantation of the uCentum™ system should be performed only by experienced spinal surgeons with specific training in the use of
this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. The surgeon treating the
patient bears the responsibility for the correct choice of patients, the required training and the experience with choosing and administering
implants. A copy of the surgical technique manual for the implantation of uCentum™ can be obtained free of charge by contacting ulrich
medical USA at the address or phone number given at the end of this document or via the internet at http://www.ulrichmedicalusa.com/
contact.
MATERIAL INFORMATION
uCentum™ is manufactured from titanium alloy (Ti-6Al-4V ELI) according to ISO 5832-3 and ASTM F136.
The materials are biocompatible, corrosion-resistant, and non-toxic under biological conditions.
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 conditions:
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 isocenter of the MRI device > 20 cm AND Scan time of a maximum of 30 min
ƒ at 3.0 T: Distance from outer edge of implant to the isocenter of the MRI device > 20 cm OR Scan time of a maximum of 15 min
Note: In the experimental test, heating of 6.1°C was measured at 3.0 T and a 15-minute scan time at 2 W/kg. At 1.5 T with a 20-cm distance
to the isocenter with a 15-minute scan time, heating of 3.0°C maximum was measured.
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.
ulrich GmbH & Co. KG l Buchbrunnenweg 12 l 89081 Ulm l Germany
Phone: +49 (0)731 9654-0 l Fax: +49 (0)731 9654-2705
spine@ulrichmedical.com l www.ulrichmedical.com
uCentum™ comprehensive posterior system

USA

BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND THE
SYSTEM-RELATED SURGICAL TECHNIQUES!
DISTRIBUTED IN THE USA BY:
ulrich medical USA Inc.
18221 Edison Avenue
Chesterfield MO 63005 | USA
12
WS 3895-eIFU
R8.1/2019-03
2019-05-06