post-market surveillance study of a skull flap fixation device: cranfixer

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 ninetyfive patients. sixty patients were selected from a list if they had at least two followups after surgery. the following variables were investigated: age, gender, number of cranfixers, device loosening, infection, and prominence. inaddition, 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 rsquo; 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 premarket test and the results of this study confirm them. cranfixer provides safe, reliable and longterm functionality.