PMCF survey for an orthodontic anchorage system

The brief

• Generate clinician-reported evidence on real-world performance and safety for post-market surveillance.
• Quantify mini-screw stability, treatment success, and any residual or unforeseen risks to patients.
• Capture component-level usability across screw, driver, power arm, and spring in routine practice.
• Identify any residual risks or unforeseen issues and deliver a dataset ready to feed the PMCF report.

The problem

No current clinician-reported evidence on real-world safety, mini-screw stability, and component usability for post-market surveillance

Our approach

A structured PMCF survey of 50 orthodontists and general practice dentists across the US, UK, and Italy, run under MRS code of conduct

• Designed a screened questionnaire covering usage history, clinical indications, procedure detail, and safety.
• Fielded online to 50 licensed clinicians, split evenly between orthodontists and general practice dentists.
• Screened on licensing, personal placement of mini screws, monthly TAD volumes, and independence from the manufacturer.
• Built in an adverse-event and complaint reporting route, with confidentiality safeguards throughout.

Key outcomes

A clean, analysis-ready dataset covering clinical indications, procedure detail, component performance, and IFU clarity

• Captured 50 QC'd responses across three markets, spanning intrusion, retraction, protraction, uprighting, and distalization.
• Quantified ease of use, reliability, likelihood to recommend, and IFU clarity and completeness.
• Rated component-level performance across screw sharpness, insertion, post strength, and spring, with safety concerns captured verbatim.
• Delivered a cleaned, coded raw data file ready for PMCF reporting and trend analysis.