Complications in maxillary distraction using the RED II device: a retrospective analysis of 21 patients

Rigid external distraction osteogenesis (DO) in the treatment of midface hypoplasia has been shown to be effective and safe, but there have been several case reports on complications. Here is presented an overview of the complications in a series of 21 patients with various craniofacial anomalies. All patients were treated using the rigid external distraction II (RED II) device after Le Fort I or III osteotomy. Distraction started 1 week postoperatively and continued until Class I occlusion was achieved; it was then continued to include a 15% overcorrection. All data were collected and categorized retrospectively from the patients' files. After a mean period of distraction of 34 days, 42 complications were reported in six different categories. Pin loosening (42.9%) and frame migrations (28.6%) were the most common complications. Of the frame migrations 25% were traumatic. Intracranial penetration of one fixation pin occurred during removal of the RED II device in one patient. From these results it can be deduced that application of the RED II device is associated with a substantial number of specific complications that mainly concern the pins of the halo-frame. The stability of the device is discussed as the distraction distance achieved was less than expected.