Intended Use; Intended Purpose; Indications; Patient Target Group/Patient Selection - KLS Martin group IPS Implants marPOR Mode D'emploi

IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use

3 Intended Use

The patient-specific implant must be applied according to the indication, see section 3.1.1 "Indications",
page 21.
The manufacturer assumes no responsibility for complications caused by improper use and/or use outside
the indication, incorrect combination of system components, surgical technique, incorrect treatment
method, or insufficient hygiene.
3.1

Intended Purpose

• Patient-specific implants are intended for the treatment of craniofacial trauma as well as reconstructive
and plastic surgeries in the craniofacial area.
• Patient-specific implants are intended for craniofacial augmentation as well as for reconstruction of
craniofacial defects.
• Patient-specific implants are intended for use in non-load-bearing applications.
3.1.1

Indications

• Treatment of craniofacial trauma
• Correction and reconstruction of craniofacial defects
• Craniofacial augmentation
• Plastic and cosmetic surgeries in the craniofacial area
3.1.2

Patient Target Group/Patient Selection

Patient-specific implants are used only for a previously identified patient known by name. They are to be
used only according to an obligatory case planning defined before the procedure.
Possible risk of injury to the patient resulting from use of the implants in skeletal structures which are
not fully grown!
Use of marPOR polyethylene implants in children or adolescents with not yet fully developed skeletal
structure is not recommended, as natural bone growth can lead to misalignment of the implant. The user
must evaluate the advantages of the use of marPOR polyethylene implants based on the potential risks for
the patient.
Revision 01 21