Spots Global Cancer Trial Database for A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

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Trial Identification

Brief Title: A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

Official Title: Clinical Evaluation of Biomet Microfixation Devices Used in Facial & Mandibular Surgical Procedures. Facial Plating System, HTR PEKK (Midface) and Mandibular Plates: A Post Market Clinical Follow-up Study

Study ID: NCT04931056

Conditions

Osteoma of Mandibular Condyle

Neuroma

Cleft Face

Hemifacial Microsomia

Treacher Collins Syndrome

Miller Syndrome

Nager Syndrome

Interventions

Titanium Facial Plates

Titanium Mandibular Plates

Add-on Condyle

HTR-PEKK

Study Description

Brief Summary: This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.

Detailed Description: The subject devices are: * plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures * plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application).