Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
Trial Parameters
Brief Summary
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Eligibility Criteria
Inclusion Criteria: 1. Skeletally mature patients at the time of surgery. 2. Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice. 3. Patients for whom data on the primary outcome variable is available. 4. Patients with data available from follow-up visits. Exclusion Criteria: 1. Patients with active infections at the time of surgery. 2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery. 3. Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices. 4. Patients who underwent secondary reconstructions with non-secondary reconstruction plates 5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.