ChM CHARSPINE system Bedienungsanleitung Seite 12

10. Bone cement should not be used because this material may cause later
removal of these implants difficult or impossible.
11. The heat generated during the curing process of the bone cement may
damage or deform the implant made of PEEK polymer.
12 POST-OPERATIVE RECOMMENDATIONS
1. It is essential to follow all of physician' s postoperative directions and warn-
ings.
2. It is essential to confirm proper position of the implant by roentgeno-
graphic examination.
3. In postoperative treatment period, the correctness of implant positioning
and immobilization of union should be confirmed by roentgenographic
examination.
4. The surgeon must instruct the patient regarding appropriate and restricted
activities during consolidation and maturation of the fusion mass in order
to prevent placing excessive stress on the implants which may lead to fixa-
tion or implant failure and further clinical problems. The implant may
break or become damaged as a result of strenuous activity or trauma,
and may need to be replaced in the future.
5. If the patient is involved in an occupation or activity which may apply
excessive stress on the implant (e.g. substantial walking, running, lifting,
or muscle strain) the surgeon must advise the patient that resultant forces
can cause implant failure.
6. Failure to perform appropriate immobilization of bone when delayed
or non-union occurs may lead to excessive fatigue stresses in the implant.
Fatigue stresses may be a potential cause of implant becoming bent, loos-
ened or fractured. If non-union of fracture or implant bending, loosening
or fracture occurs, the patient should be immediately revised, and the im-
plants should be removed before any serious injuries occur. The patient
must be appropriately warned about these risks and closely monitored
to ensure compliance during the treatment until the bone union is con-
firmed.
7. The patient should be warned about the risk should he fail to follow
the above-mentioned rules, or should he be unavailable for follow-up
clinical examination.
8. The surgeon must instruct the patient to report any unusual changes
of the operative site to his/her physician. If any change at the site has
been detected, the patient should be closely monitored.
9. The patient should be informed about the type of implant material.
10. The patient should be warned to inform the medical staff about the in-
serted implants prior to any MRI procedure.
11. The patient should be advised not to smoke or consume alcohol excessively
during the period of treatment.
13 CONSIDERATIONS FOR REMOVAL OF THE IMPLANT
AFTER TREATMENT
1. When fusion occurs, the device will be deeply integrated into the bone
and should not be removed unless the management of a complication
or adverse event requires the removal.
If this instruction appears unclear, please contact the manufacturer, who shall
provide all required explanations.
Updated INSTRUCTIONS FOR USE are available at the following website:
www.chm.eu
IFU-017/06.18; Date of verification: June 2018
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