9
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.
6.3 Intraoperative
The implant is delivered sterile and must not be resterilized.
Do not use the implant if the packaging is damaged or was opened outside the sterile area.
Do not use the implant if the expiry date has passed.
Use aseptic techniques in order to avoid contamination when taking the implant out of the sterile packaging and when using the implant.
tezo-P implants are intended exclusively for use in pairs in the intervertebral space.
After the implant has been in contact with a patient, has been soiled or used, it must not be reused and must be discarded. Even if the
exterior of the implant appears unchanged, prior stress may have caused damage that can lead to implant failure.
To achieve fusion, the implant should always be inserted into the intervertebral space with bone or bone graft material.
6.4 Postoperative
The patient should be instructed to inform his or her treating physician immediately regarding any unusual changes in the area where
the surgery was performed.
The patient should be monitored for any changes to the implant area. The treating physician should assess the potential for clinical
implant failure and discuss with the patient the necessary measures to promote further healing.
The inserted implant serves to reconstruct substance defects of the surgical site over a maximum two-year healing process. After the
surgical site is fused, the implant is firmly anchored in the bone. The implant is therefore not intended to be removed unless there are
complications, implant failure, or a delayed healing phase (no fusion within 2 years) that require implant removal. The decision to do so
should only be made after a meticulous risk to benefit assessment by a medical specialist.
The following complications can occur due to the presence of the implant in the body:
1. Corrosion, with local tissue inflammation or pain
2. Implant migration, possibly leading to injuries
3. Risk of additional injuries, caused by post-surgical trauma
4. Distortion, loosening or breakage
5. Pain, symptoms or unusual sensitivity due to the presence of the implant
6. Risk of infection or inflammation
7. Bone loss due to stress shielding
8. Potential, unknown or unexpected long-term effects
A prolonged healing phase, unsuccessful bony fusion or subsequent bone resorption or trauma can place undue stress on the implant,
which, in turn, could lead to implant failure.
Implant failure is possible even after successful fusion.
The implant removal must be followed up accordingly.
Explanted implants must not be reused.
The patient should be informed about the necessary behavior after the implantation procedure, including measures to be taken in case of
an event involving the implant. An implant card should be given to the patient.
7 Recommended application
Further description of the tezo application is included in the surgical technique, prepared as part of the overall documentation of the system.
It is also available at
.
8 Material Information
The tezo implants are manufactured from a titanium alloy according to ISO 5832-3; ASTM F136. The devices are biocompatible, corrosion-re-
sistant and non-toxic in the intended use as per EN ISO 10993-1.
9 MRI Information
MR
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
2019-07-02
