A Cohort Study for Clinical Evaluation of OmniMax MMF System

The objective of this study is to highlight and evaluate the clinical benefits of OmniMax MMF
system applied to patients undergoing repair of uncomplicated mandibular fracture(s). A total
of 50 subjects involved in trauma events resulting in uncomplicated mandibular fracture(s)
will be enrolled at up to 5 sites from 3 surgical subspecialties: maxillofacial surgery, ENT,
and plastic surgery. Subjects considered for participation will receive OmniMax MMF system
for maxillo-mandibular fixation for a period of 4 to 8 weeks. Incidence of root damage
associated with screw insertion, time for implantation and removal of the device, oral
hygiene during the maxillomandibular fixation period, mucosal overgrowth, gingival necrosis,
post-operative pain, stability of the occlusion, fracture healing, patient overall
satisfaction/compliance with length of treatment, incidence of glove perforation and
accidental puncture, will be evaluated in all participants who remain in IMF
post-operatively. Adverse Events associated with the use of OmniMax MMF system will also be
collected.

Inclusion Criteria:

- Males or females

- 18 years of age or older

- Able and willing to sign ICF and medical photography consent

- Undergoing a surgical procedure to repair uncomplicated mandibular fracture(s)
requiring open reduction internal fixation (ORIF) or closed maxillo-mandibular
fixation (MMF)

- Fracture repair done within 10 days after facial trauma

- Use of OmniMax MMF system as a single mean for IMF (maxillary plate and mandibular
plates together with no other device combined, such as Erich bars or IMF screws).

Exclusion Criteria:

- General contraindications unfavorable for the use of MMF (psychological disorders,
seizures disorders, airway compromise, immune-compromised patients, etc).

- History of radiation therapy to the head or neck region.

- Limited blood supply to the area of device application.

- Insufficient quantity or quality of bone.

- History of foreign body sensitivity.

- History of previous use of bisphosphonates (i.e. alendronate, pamidronate,
neridronate, olpadronate, ibandronate, risendronate, zolendronate).

- Clinically active or latent infection.

- Patients with less than 20 teeth.

- Deciduous dentition.

- Patients for whom the use of OmniMax MMF system would not be appropriate in judgment
of the surgeon (i.e., excessive overjet or deep overbite).

- Mandibular fracture pattern that could prevent the use of OmniMax MMF system for
adequate reduction and stabilization (i.e., comminuted fractures, dental alveolar
fractures).