Hotline; Case Planning - KLS Martin group IPS Implants marPOR Mode D'emploi

IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
fulfills the basic requirements for the safety and performance of medical devices within the meaning of the
applicable European regulations.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · 78532 Tuttlingen · Germany
Postfach 60 · 78501 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com
2.1

Hotline

If you have questions about how to use this product or questions about clinical applications, please contact
the product management team:
Tel: +49 7461 706-216
Fax: +49 7461 706-350
All serious incidents occurring in connection with the product shall be reported immediately to the
manufacturer and to the competent authority. An "incident" is a malfunction or deterioration of the
properties or performance of the product. This also includes application errors due to ergonomic features,
inadequacies of this leaflet and undesirable side effects. An incident is considered "serious" if it has, could
have had, or might have, directly or indirectly, any of the consequences listed below:
• death of a patient, user or other person,
• temporary or permanent serious deterioration of the health of a patient, user or other person,
• a serious threat to public health.
Each patient-specific implant and its packaging are marked with an individual case number. Please always
provide the case number in case of a complaint.
Shipping contaminated products could result in the death of or serious injury to third parties!
In case of return shipments send only clean and disinfected products in sterile packing.
2.2

Case Planning

Patient-specific implants are created following detailed individual case planning by the manufacturer in
coordination with a qualified user. Each implant is created exclusively for a previously identified patient
known by name.
Revision 01 19