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
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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
LANGUAGE:
English
The only version applicable to users in the U.S. is the version intended especially for the United States.
The only version applicable to users in Canada is the version intended especially for Canada.
Read all instructions carefully. Failure to follow instructions, warnings and precautionary measures
may have severe consequences or result in patient injury.
Take into careful consideration all product materials before clinical use.
The required product materials prepared as overall documentation of the system are: system related
instructions for use, surgical technique and, if applicable, supplements, assembly and disassembly
instructions, as well as "Processing manual implants and instruments" UH 1100.
1 Intended use
tezo is an implant group – consisting of tezo-P, tezo-T, tezo-A – for support of the intervertebral space in the lumbar and lumbosacral spine
in humans with the purpose of supporting bone fusion of the vertebral bodies. tezo is inserted individually or in pairs between two vertebral
bodies. The implants can also serve as a means of restoring the spinal profile. To achieve fusion, the implant should always be inserted with
bone or bone graft material into the intervertebral space. Additional stabilizing instrumentation is necessary, for example, with a pedicle
screw-rod system.
2 Product description
tezo are implants for lumbosacral interbody fusion. The ALIF technique (Anterior Lumbar Interbody Fusion), the PLIF technique (Posterior
Lumbar Interbody Fusion) or the TLIF technique (Transforaminal Lumbar Interbody Fusion) can be used. The cages can be used for bridging and
stabilizing the intervertebral space with the purpose of supporting bony fusion. The reconstruction of the spinal profile is achieved through
the size, height, and angulation of the cages, among others. The cages are to be filled with bone/bone graft material and provide optimal
space for bony fusion.
3 Indications
Indications for fusion procedures are for example:
Patients with infections associated with the spine (e.g. spondylodiscitis)
Degenerative disk disease
Post-diskectomy syndrome
Revision following disk surgery
Degenerative instability
Lytic spondylolisthesis
Congenital malposition such as scoliosis
Spinal stenosis with clinical instability
Pseudarthrosis
4 Contraindications
Patients with fever or leukocytosis
Patients with a history of material allergy or patients who tend to react to foreign bodies
Patients whose general medical or psychological condition is unfavorable for- or could be worsened by the procedure; careful consideration
is required on the part of the treating physician/surgeon for these patients
Patients with inadequate bone quality or quantity (e.g. severe osteoporosis, osteopenia, osteomyelitis)
Pregnancy
5 Possible side effects
Possible complications associated with the implant are:
Implant loosening, dislocation and/or implant failure
2019-07-02
