Instructions for Use
Rotterdam Palatal Distractor
6
Contraindications
WARNING
Non-observance of the contraindications poses a danger of serious or even lethal
patient injury!
Extremely low palate
•
In case of an extremely low palate, the supporting plates of the distractor lose their grip
and the distractor loses its stability.
•
Class II overbites
In case of class II overbites, the distractor or the activation spindle may come into contact
with the mandible teeth. This can be avoided by mounting the distractor higher in the
palatal chamber in distal direction or by wearing a mouth-guard during the distraction and
consolidation phase.
Obvious infections
•
Suspected sensitivity or allergies to the implant materials used
•
Autoimmune disease
•
Circulatory problems, systemic diseases and metabolic disorders
•
Insufficient or inadequate hard and soft tissue
•
Bone tumors located in the implant base region
•
Secondary diseases such as degenerative processes that may adversely affect the healing
•
process
Regions exposed to inadequately high forces or excessive weight loads
•
Patients unwilling or unable to follow instructions during the postoperative phase due to
•
their mental, neurological or physical condition
Patients in a poor condition of health in the sense of a general contraindication
•
(e.g. irradiation patients)
•
Osteoporosis or osteomalacia or other severe structural bone damage that prevents the
stable fixation of implant components
Obvious drug or alcohol abuse
•
V. 2.1
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