Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Surgeon iD Mandible Reconstruction Plates
Stryker Craniomaxillofacial
50 participants
Dec 1, 2024
OBSERVATIONAL
Conditions
Summary
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Eligibility
Inclusion Criteria2
- Patients who underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate implant as per routine clinical practice.
- Patients for whom data on the primary outcome variable is available.
Exclusion Criteria4
- Patients with active local infections at the time of surgery.
- Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
- Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions.
- Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery
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Interventions
Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07221916