WS 3495-eIFU
R6.1/2019-03
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
[email protected] l www.ulrichmedical.com
12
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.
SYSTEM:
tezo™ titanium cage family
COUNTRY:
USA
The only version applicable to users in Canada is the version intended especially for
Canada.
!
Rx only
BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND THE SYSTEM-
RELATED SURGICAL TECHNIQUE!
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MANUFACTURER:
DISTRIBUTED IN THE USA BY:
ulrich GmbH & Co. KG
ulrich medical USA Inc.
Buchbrunnenweg 12 l 89081 Ulm l Germany
18221 Edison Avenue l Chesterfield MO 63005 l USA
DESCRIPTION
The tezo™ Titanium Cage Family – consisting of tezo-P, tezo-T and tezo-A – is used for the surgical stabilization of the lumbosacral spine to
provide a suitable environment for fusion to occur. The system components include intervertebral devices available in a variety of height,
length, width and anteroposterior angulation combinations to accommodate differing patient anatomy.
Precaution:
The implantation of tezo™ 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 tezo™ 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 send an email to [email protected].
MATERIAL INFORMATION
The tezo™ implants are manufactured from titanium alloy material (Ti-6Al-4V ELI) conforming to ASTM F136. The materials are biocompatible,
corrosion-resistant, non-toxic under biological conditions.
MR
MR conditional
MRI information
ulrich medical tezo 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 tezo implant
can undergo an MRI examination under the following conditions:
Field strengths of 1.5 T and 3.0 T
highest field gradient of 30 T/m (3000 G/cm) or less
maximum specific absorption rate (SAR) of 2 W/kg for normal operating mode for a scan time of 30 minutes or 4 W/kg for the first level
controlled mode for a scan time of 15 minutes
Note:
In the experimental test, heating of a maximum of 6.0°C was measured at:
1.5 T and 3.0 T
a 15-minute scan time
SAR 4 W/kg
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 22 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°
2019-07-02
