Patient Target Group; Users; Environmental Conditions During Use - KLS Martin group L1 Rib Gebrauchsanweisung

In general, all surgical procedures are associated with the risk of possible adverse effects and
complications. In most cases, these are not caused by the product used, but rather due to clinical
conditions.
The possible general adverse effects that may occur in relation to the use of an osteosynthesis system
include:
• Nonunion or delayed union which may lead to breakage of the implant
• Bending or fracture of the implant
• Metal sensitivity or allergic reaction to a foreign body
• Decrease in bone density due to stress shielding
• Pain, discomfort or abnormal sensations due to presence of device
• Nerve damage due to surgical trauma
• Necrosis of bone
• Implant migration
The user is responsible for informing patients about possible adverse effects and complications.
3.5

Patient target group

The L1 Rib Plating System is indicated for use in skeletally mature patients.
3.6

Users

Professional users:
The products are to be used exclusively by qualified surgical staff.
Cleaning, disinfection and sterilization are carried out by trained qualified staff in the processing unit for
medical products.
The user bears the responsibility for:
• Selection and proper execution of the surgical procedure
• Compilation of the product components and their proper use
• Avoiding or minimizing the general risks posed by surgical interventions
• Obtaining informed consent from, instructing, and taking post-operative care of the patient
3.7

Environmental conditions during use

The products may be used only in rooms intended for medical purposes under operation conditions.
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L1 Rib
Instructions for Use
Revi sion 01