General Information - ulrich medical ADDplus Instrucciones De Uso

ƒ Errors in implant selection could result in premature clinical implant failure. The number of segments to be treated has to be determined
accurately. The shape and composition of human bones limits the size and durability of the implant.
ƒ After the implant has been used once, it must not be used again. Even if the implant appears undamaged, previous strain may have resulted
in irregularities that could shorten the implant life. Only new, undamaged implants may be used. Used or potentially damaged implants
must be discarded.
ƒ The patient should be instructed to inform his or her treating physician immediately regarding any unusual changes in the area where the
surgery was performed. The patient should be monitored if any change is detected in the implant area. The treating physician should assess
the potential for clinical implant failure due to such changes and meet with the patient to discuss the necessary measures to promote
continued healing.
ƒ The product must be handled and stored carefully. Damages or scratches on the implant can have a significant negative impact on the
product's stability and resistance to fatigue.
Before use, carefully check the protective packaging for damage which could impair the sterility of the product.
POSSIBLE COMPLICATIONS
In many cases, potential complications are more likely caused by the application than by the implant:
ƒ General risks and complications caused by the operation
ƒ Wound healing disorder
ƒ Infection
ƒ Lung complications
ƒ Cardiovascular complications, such as blood loss, thrombosis, embolism, coagulopathy
ƒ Gastrointestinal complications, such as gastritis, ileus, ulcer
ƒ Neurological complications, such as spinal or root lesions with temporary or permanent sensory and/or motor restrictions (bladder and
colonic disorders, sexual dysfunctions)
ƒ Risk of narcosis, blood transfusion risks, postural damage
ƒ Intraoperative injury to blood vessels, massive hemorrhage, stroke, cerebral hemorrhage with potential life-threatening consequences
ƒ Injury to organs adjacent to the spine, such as cervical viscera, thoracic and abdominal organs depending on the region operated on
ƒ Failure of bone fusion and need for restabilization
ƒ Implant removal or restabilization due to loosening, dislocation and/or failure of the implant
ƒ Local or systemic reactions due to material intolerance
ƒ Insufficient alleviation of complaint
These possible complications can require further operative interventions.
USE OF GENUINE PRODUCTS
Implants and instruments are developed and manufactured for common use. Unforeseeable risks and/or contamination of the materials may
result from using the products of other manufacturers with those from ulrich medical, or implants and instruments may not fit together so
that the patient, user or third party may be put at risk. The combination of implants is only possible with implant components of this system
unless otherwise stated in the application instructions. Only genuine instruments from the implant system which are exclusively designed for
the purpose may be used for handling the implants. Please refer to the special handling instructions on the packaging insert of the respective
instrument. Only genuine implants must be used.
CLEANING, DISINFECTION AND STERILIZATION
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General information

For the cleaning, disinfection and sterilization of unsterilized implants and instruments, we refer to UH 1100 „Processing manual implants
and instruments". For individual instruments which are correspondingly marked in the system-related surgical technique (
the „Assembly and disassembly instructions with special cleaning instructions". You can download them any time free of charge at: www.ifu.
ulrichmedical.com
Basic principles
Unsterilized implants must be thoroughly cleaned, disinfected and sterilized before use (clean and disinfect after removing the transport
packaging and sterilize after packaging). Under no circumstances may implants which have already been in contact with a patient or have
become contaminated be used again; these must be discarded.
Pretreatment
Clean/disinfect implants which you have touched, return them to the implant storage tray and sterilize the implant storage tray when it is
fully loaded. Never use wire brushes or steel wool to clean any implants, implant storage trays or sterilization containers. Never apply oil and
This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
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2020-03-13