A 17-year-old boy with bilateral complete cleft lip and palate exhibited severe maxillary hypoplasia. The clinical manifestation was a concave profile anteriorly and a bilateral posterior cross-bite with class III malocclusion and missing maxillary incisors. Orthodontic preparation included fabrication of the maxillary surgical splint and cementation of it 5 days before surgical intervention for adaptation purposes. A Le Fort I osteotomy was performed and the maxilla was separated from the pterygoid plates. A Rigid External Distraction II system was placed to allow anterior traction of the maxilla. Three pins were placed on each side of the skull in the anterolateral portion of the head, torqued only to finger tightness (Fig. 1).
Twenty-four hours postoperatively, the patient experienced severe headaches, fatigue, and dizziness. A postoperative computed tomography scan showed a 0.5-cm penetration of the right middle cranial pin intracranially with a local fracture of the skull (Fig. 2). The halo device and the cranial pins were repositioned accordingly and another postoperative computed tomography scan was performed to confirm the correct positioning of the pins. The patient started broad-spectrum antibiotic therapy. Forty-eight hours later, the general symptoms disappeared and the patient was monitored on a regular basis until discharge from the hospital. The remaining distraction course proceeded as planned.
Distraction osteogenesis of the midface using rigid external distraction offers new possibilities for the treatment of large sagittal discrepancies, but this system is not risk-free. Complications associated with the halo have frequently been reported in the orthopedic literature and include loosening of pins, soft-tissue infection around the pins, severe pain associated with pins, scarring around the pins, dysphagia, neural injury, pin penetration with or without cerebrospinal fluid leak, and cerebral or epidural abscess.1 Similar complications have been reported lately with the growing use of the rigid external distraction device.2–5
Use of the halo in children is especially associated with significantly high complication rates. These complications are similar to those reported in an adult population, except for a higher incidence of pin-site infection.2 The thickness of the safe area for pin placement in children was studied and found to be in the posterolateral and anterolateral sites.6 The ring should be placed just over the eyebrows and the anterior pins over the lateral one-third of the orbit.6
The skull fracture and pin penetration in our case probably happened during device application intraoperatively, although no signs or symptoms were immediately recorded. The patient’s complaints began only 24 hours postoperatively. Application of the rigid external distraction device during surgery was performed according to the above-mentioned protocol.
On the basis of this case report, we recommend that a computed tomography scan be performed before halo application because of the variability in skull thickness, even in the safe areas. Pediatric neurosurgical consultation and specific localized pin insertion are recommended in any case when using rigid external distraction. If there is a question as to correct pin placement, a postoperative computed tomography scan should be obtained. Some patients with an extremely thin cortex may not be candidates for external distraction devices that use a halo.
Dror Aizenbud, D.M.D., M.Sc.
Orthodontic and Cleft Palate Unit
Adi Rachmiel, D.M.D., Ph.D.
Department of Oral and Maxillofacial Surgery
Rambam Medical Center
Technion Faculty of Medicine
1. Garfin, S. R., Butt, M. J., Waters, R. L., and Nickel, V. L. Complications in the use of the halo fixation device. J. Bone Joint Surg. (Am.)
68: 320, 1986.
2. Le, B. T., Eyre, J. M., Wehby, M. C., and Wheatley, M. J. Intracranial migration of halo fixation pins: A complication of using an extraoral distraction device. Cleft Palate Craniofac. J.
38: 401, 2001.
3. Mavili, M. E., Vargel, I., and Tuncbilek, G. Stoppers in RED II distraction device: Is it possible to prevent pin migration? J. Craniofac. Surg.
15: 377, 2004.
4. van der Meulen, J., Wolvius, E., van der Wal, K., Prahl, B., and Vaandrager, M. Prevention of halo pin complications in post-cranioplasty patients. J. Craniomaxillofac. Surg.
33: 145, 2005.
5. Rieger, J., Jackson, I. T., Topf, J. S., and Audet, B. Traumatic cranial injury sustained from a fall on the rigid external distraction device. J. Craniofac. Surg.
12: 237, 2001.
6. Garfin, S. R., Botte, M. I., Centeno, R. S., and Nickel, V. L. Osteology of the skull as it affects halo pin placement. Spine
10: 696, 1985.
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