Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer

Abstract

Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover. The effectiveness and safety of this commercial medical device were investigated in detail by the regulatory auditors. Methods and Materials/Patients: Cranfixer was used for ninety-five patients. Sixty patients were selected from a list if they had at least two follow-ups after surgery. The following variables were investigated: age, gender, number of Cranfixers, device loosening, infection, and prominence. In addition, a retrospective review was performed about the reason of surgery. Results: Flap loosening and infection were the major variables surveyed. On average, two Cranfixers were used for each patient. Patients’ median age was 44 years. There was no sex preference (50% male). The craniotomy occurred in the frontal (50%), occipital (3%), parietal (20%), and temporal (27%) lobes. Based on examination and CT imaging, no cases of loosening were observed. Just in one patient, one of two Cranfixers was infected (P<0.001). Conclusion: The reliability and functionality of Cranfixer were proved in pre-market test and the results of this study confirm them. Cranfixer provides safe, reliable and long-term functionality.

Keywords

• internal fixators
• skull
• burrhole cover
• cranfixer
• product surveillance
• postmarketing