ulrich medical tezo titanium cage Series Instructions For Use Manual page 13

The SE sequence demonstrates reduced artefacts (≤ 10 mm).
The attending physician should conduct a careful risk/benefit assessment.
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.
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 af-
tercare 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
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WARNINGS AND PRECAUTIONS
ƒ This product may only be used by an experienced surgeon/physician of spinal surgery.
ƒ The attending surgeon is responsible for the correct selection of patients, the training required and experience in the selection and place-
ment of the implants.
ƒ The patient must be given detailed information on the risks involved from the intervention and the use of the implant.
ƒ The surgeon/physician should discuss with the patient in detail the expected surgical result from the use of this product, particularly with
regard to possible physical limitations of the product. The postoperative level of activity will influence the service life of the implant and the
durability of the implant in the bone. The patient must therefore be instructed about restrictions and risks in daily activities and any special
rules of behavior that may be necessary. Compliance with the surgeon/physician's instructions is required. Special attention should be paid
to a postoperative conference and the necessity of regular medical follow-up examinations.
ƒ The correct selection and placement of the implant must be ensured and reviewed using appropriate pre-, intra- and postoperative diag-
nostic methods. Use of a C-arm is strongly recommended.
ƒ Errors in the choice of implant may lead to premature clinical implant failure. The number of segments has to be selected accurately. The
product should be used in the correct anatomic position, taking into consideration current standards for interbody fusion. The human
bone limits the size and resistance of the implant due to its shape and composition. Over the long term, the implant cannot withstand the
physiological, biomechanical forces without successful fusion of the bone. An implant which was initially implanted firmly may loosen over
time or its function become impaired.
ƒ The product must be handled and stored with care. Damage or scratches on the implant can considerably impair the firmness of the product
and its resistance to fatigue.
ƒ After the product has been used once, it cannot be used again under any circumstance. Even if the product appears to be undamaged,
previous strains can lead to irregularities which can shorten the lifespan of the product. Only new and undamaged implants must be used.
Used or damaged implants must be disposed of.
ƒ The patient should be instructed to inform their surgeon/physician immediately regarding any unusual changes in the area of the operation.
The patient should be monitored in case any changes appear in the region of instrumentation. The surgeon/physician must then evaluate
whether clinical failure of the implant is occurred and discuss with the patient any necessary measures which must be taken to promote
further healing.
ƒ A delayed healing phase, lack of bone consolidation or subsequent bone resorption or trauma can lead to excessive stress on the implant
and loosening, deformation, cracking or breakage of the implant.
ƒ Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous
surgery.
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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2019-07-02