OsteoMed Spectrum LeFort III Mid-face Distraction System Surgical Technique

INDICATIONS: The OSTEOMED SpectrumTM Mid-face Distraction System is indicated for use in the treatment of cranial or mid-face conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and micrognathia. The OSTEOMED SpectrumTM Mid-face Distraction device is intended to provide temporary stabilization and gradual lengthening of the cranial or midfacial bones. This device is intended to be removed after consolidation. The OSTEOMED Spectrum Mid-face Distraction System is intended for single patient use only. CONTRAINDICATIONS: Use of the OSTEOMED SpectrumTM Mid-face Distraction System is contraindicated in cases of active or suspected infection, in patients previously sensitized to titanium or silicone; in patients with certain metabolic diseases, or patients who are immune compromised. It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of distraction osteogenesis. The OSTEOMED SpectrumTM Mid-face Distraction System is also contraindicated in those cases where there is an inadequate volume or quality of bone to place the distractor securely.