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.
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.
In order to achieve fusion, bone or bone graft material should be grafted to the implant.
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 may 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 obelisc application is included in the surgical technique, prepared as part of the overall documentation of the
system. It is also available at
www.ifu.ulrichmedical.com
.
8 Material information
The obelisc implants are manufactured from a titanium alloy according to ISO 5832-3 and ASTM F136.
The devices are biocompatible, corrosionresistant and non-toxic in the intended use as per EN ISO 10993-1.
9 MRI information
MR
ulrich medical obelisc implants are classified as “MR Conditional” according to ASTM standard F2503.
The “MR Conditional” components are tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with an obelisc
implant can undergo an MRI examination under the following circumstances:
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 the normal operating mode for a scan time of 30 minutes
Note:
Under experimental conditions, maximum heating of 5.0°C was measured at:
1.5 and 3.0 T
15-minute scan time
SAR 2W/kg
These scan conditions allow low-risk examination of patients. To minimize heating, the scan time should be kept as short as possible and the
SAR as low as possible.
Artifacts:
MR imaging in the area of the implants can be impaired by artifacts. Under experimental conditions, artifacts up to 30 mm were
detected 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°
2019-09-10
