Device Malfunction Associated With Mandibular Distraction for Infants With Robin Sequence.

INTRODUCTION: Mandibular distraction osteogenesis (MDO) effectively treats upper airway obstruction (UAO) in young patients with Robin sequence (RS). The most commonly used MDO devices have internal and external components that require manual activation. Although complications associated with MDO in infants with RS have been well documented, hardware/device malfunction has not been precisely described. The present study reports the authors' recent experiences with such problems, in an effort to shed light on these complications and identify potential steps to mitigate future related issues. DESIGN: The authors reviewed a prospectively gathered database to identify all young children under the age of 3 years who underwent MDO using buried internal devices for UAO associated with grade 3 RS from March 2007 to September 2019. We specifically focused on complications attributable to the hardware itself. RESULTS: Nineteen patients with 40 devices met inclusion criteria. The median age at MDO was 2.3 months (interquartile range 1.4-6.3 months). Intraoperative activation of all devices under direct vision resulted in satisfactory distraction. Four devices (10.5%) developed postoperative complications directly related to the device, including break down of component parts (N = 3) and failure to maintain distraction distance (N = 1). Two patients required surgical replacement of one device each, whereas the remaining complications occurred during the consolidation phase and did not require intervention. CONCLUSIONS: This report documents a series of device/hardware malfunction in infants and young children undergoing MDO for severe UAO associated with RS. Despite rigorous testing and development, these devices may fail, resulting in patient morbidity.