Instructions for Use
Rotterdam-Midline Distractor / Bologna-Midline Distractor
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Intraoperative Procedure
The surgery is performed under general anesthesia, preferably with endotracheal intubation.
After a vestibular incision according to the current state of the art, the periosteum is removed
labially in the symphysis area, and the corticalis is exposed.
The planned vertical interdental osteotomy line is planned and marked accordingly. The
distractor is positioned at the desired location on the bone.
In order to ensure good contact to the cortical bone, the osteosynthesis plates can be adapted
to the patient's anatomical situation by slightly bending them. Bending of the plates is done
using two bending pliers (item no. 25-516-13-07).
Excessive bending of the osteosynthesis plates or bending of the distractor corpus may lead to
breaking or failure of the distractor and is therefore not allowed.
The distractor is temporally fixed monocortically with at least one osteosynthesis screw (see
section 10 "Selecting the Distraction System", page 33) per side of the planned osteotomy
line, taking the distraction vector into consideration.
The distractor is then removed again after loosening the osteosynthesis screws, and the
bicortical osteotomy is performed according to the current state of the art. The symphysis is
split in two parts.
After successful osteotomy, the distractor can be fully inserted. In case of the Rotterdam
Midline Distractor, the fixation is done bicortically using at least three osteosynthesis screws
per osteosynthesis plate.
The Bologna Midline Distractor is fixed monocortically using eight screws. The distractor can
also be anchored dentally. To this purpose, stainless steel pins are attached to the cranial end
of the distractor that are fixed to the teeth by means of a bracket fixation. This treatment
method allows alignment of the dental arch already during distraction. Any occurring forces are
distributed over teeth and bone; a potential overloading of the mandibular joint or locking of
the teeth is avoided.
Make sure that the holes which were initially used for temporary fixing must be fitted with
emergency screws (see section 10 "Selecting the Distraction System", page 33).
The correct function of the distractor must be checked already during surgery by activating the
apparatus for a few millimeters.
The distraction vector and any obstructions can be controlled and corrected, if necessary.
Afterwards return the distractor to the initial position. The distractor corpus and the activation
point must remain accessible after closure of the wound.
V. 3.0
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