Canada - ulrich medical tezo titanium cage Series Instructions For Use Manual

SYSTEM: tezo™ titanium cage family

Canada

COUNTRY:
The only version applicable to users in the U.S. is the version intended especially for the United States.
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 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.
2 Indications/Intended use
tezo is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of
non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc di-
sease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
3 Contraindications
ƒ Patients with fever or leukocytosis
ƒ Patients with spine associated infections (e.g. spondylodiscitis)
ƒ Patients with proven material allergy or tendency to react to foreign bodies
ƒ Patients with obesity
ƒ Patients without adequate compliance who are not able due to their mental and/or neurological state or capable of adhering to the
aftercare instructions
ƒ Patients with a poor general medical or psychological condition which could be further exacerbated by the intervention; in these patients
the attending surgeon/physician must carefully weigh the risks and benefits
ƒ Patients with inadequate bone quality or quantity, e.g. severe osteoporosis, osteopenia, osteomyelitis
ƒ Patients who are pregnant
ƒ Patients with a prior fusion at the level to be treated.
ƒ Patients with any condition not described in the Indications for Use
4 Possible side effects
Possible complications associated with the implant are:
ƒ Implant loosening, dislocation and/or implant failure
ƒ Local or systemic reactions due to material intolerance
ƒ Failure of bony fusion
ƒ Adjacent segment degeneration
These possible complications may lead to further surgical interventions (implant removal or stabilization renewal). Other complications which
may be caused by the surgical procedure itself and independent of the implant are:
ƒ General surgical risks and complications
ƒ Anesthesia and blood transfusion risks as well as positioning damage
ƒ Lung complications
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
18
WS 3495-eIFU
R6.1/2019-03
2019-07-02