Environmental Conditions During Use; Users; Contraindications; Potential Side Effects And Residual Risks - KLS Martin group IPS Implants marPOR Mode D'emploi

3.1.3

Environmental conditions during use

The products may be used only in rooms intended for medical purposes under sterile operation conditions.
3.1.4

Users

The products may be used only by expert medical staff who are qualified to use the products based on their
specialized training, their knowledge and experience, as well as their knowledge of the relevant regulations.
The user must know and have mastered the adequate surgical technique and the product as a whole.
The user bears the responsibility for:
• Thorough study of the case-specific product documentation
• Selection and proper execution of the surgical procedure
• Compilation of the product components and their proper use as defined in the case planning
• Avoiding or minimizing the general risks posed by surgical interventions
• Obtaining informed consent from, instructing, and taking post-operative care of the patient
3.2

Contraindications

The contraindications include, but are not limited to, the following points.
Possible risk to life of patients in case of non-observance of contraindications!
• Manifest infection in the vicinity of the location to be treated
• Material sensitivity or allergies to the implant materials used
• Quantitatively and/or qualitatively insufficient hard and/or soft tissue
• Patients who are unwilling or unable to follow instructions during the entire treatment including the
post-operative phase
• Use outside the areas defined in the case planning
• Use in load-bearing areas such as the temporomandibular joint (TMJ)
• Use in areas exposed to the outside environment, e. g. sinuses
• Use in tissue damaged by oncological treatments
3.3

Potential Side Effects and Residual Risks

Surgical procedures always carry a danger of adverse effects and residual risks. In most cases, these are not
caused by the product used, but rather due to clinical conditions. The possible general adverse
effects/residual risks that may occur in relation to the use of a patient-specific implant include:
• Loosening of the implant
• Breaking of the implant
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IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
Revision 01