Intended Use; Intended Purpose; Indications; Patient Group/Patient Selection - KLS Martin group Reconstruction de l'avant-bras IPS Implants Mode D'emploi

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Intended Use

3.1

Intended Purpose

• Anatomical model
The IPS® Implants Forearm Reconstruction anatomical model is intended for visualization of the anatomical
situation and accuracy of fit as well as further planning in case of improperly healed forearm fractures or
congenital malformations of the forearm.
• Drill and marking guide
The IPS® Implants Forearm Reconstruction drill and marking guide is made of polyamide and is intended for
pre-drilling at the position and in the angle planned before the procedure. Furthermore, the intended saw
cut is marked using the guide.
• Patient-specific implant
The IPS® Implants Forearm Reconstruction implant is intended for treatment of improperly healed forearm
fractures or congenital malformations of the forearm.
The system must be applied according to the indication, see section 3.1.1 "Indications", page 34.
Gebrüder Martin assumes no responsibility for complications caused by improper use, incorrect indication,
incorrect combination of system components and surgical technique, or limitations of the treatment
method or insufficient hygiene.
The system must be applied according to the indication, see section 3.1.1 "Indications", page 34.
Gebrüder Martin assumes no responsibility for complications caused by improper use, incorrect indication,
incorrect combination of system components and surgical technique, or limitations of the treatment
method or insufficient hygiene.
3.1.1

Indications

The patient-specific IPS® Implants Forearm Reconstruction implant, the patient-specific IPS® Implants
Forearm Reconstruction drill and marking guide, and the patient-specific IPS® Implants Forearm
Reconstruction anatomical model are intended for surgical, reconstructive procedures that require internal
fixation with an implant for alignment, reconstruction and stabilization of bone tissue.
3.1.2

Patient Group/Patient Selection

Patient-specific products are used by a qualified user only for a previously identified patient known by name.
They are to be used only according to the case planning defined before the procedure.
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Instructions for Use
IPS® Implants Forearm Reconstruction
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