en Basic Neurosurgery Clinical Trial <strong>Background and Aim: </strong>Cranfixer was approved in 2017 by the Food and Drug Administration of Iran&nbsp;as a skull flap fixation and also a burr hole cover. The effectiveness and safety of this commercial&nbsp;medical device were investigated in detail by the regulatory auditors.<br> <strong>Methods and Materials/Patients:</strong> Cranfixer was used for ninety-five patients. Sixty patients were&nbsp;selected from a list if they had at least two follow-ups after surgery. The following variables were&nbsp;investigated: age, gender, number of Cranfixers, device loosening, infection, and prominence. In<br> addition, a retrospective review was performed about the reason of surgery.<br> <strong>Results:</strong> Flap loosening and infection were the major variables surveyed. On average, two Cranfixers&nbsp;were used for each patient. Patients&rsquo; median age was 44 years. There was no sex preference (50%&nbsp;male). The craniotomy occurred in the frontal (50%), occipital (3%), parietal (20%), and temporal (27%)<br> lobes. Based on examination and CT imaging, no cases of loosening were observed. Just in one&nbsp;patient, one of two Cranfixers was infected (P<0.001).<br> <strong>Conclusion: </strong>The reliability and functionality of Cranfixer were proved in pre-market test and the&nbsp;results of this study confirm them. Cranfixer provides safe, reliable and long-term functionality. Internal fixators, Skull, Burrhole cover, Cranfixer, Product surveillance, Postmarketing 54 62 http://irjns.org/browse.php?a_code=A-10-264-1&slc_lang=en&sid=1 Seyed Roholah Ghodsi roholahghodsi@gmail.com (Corresponding author) 10031947532846005131 10031947532846005131 Yes DanaWell Company, Tehran University of Medical Sciences, Tehran, Iran Hosein Esmaili Dezaki hesmaeilid@gmail.com 10031947532846005132 10031947532846005132 No DanaWell Company, Tehran University of Medical Sciences, Tehran, Iran Morteza Alizadeh mor1361@gmail.com 10031947532846005133 10031947532846005133 No . Department of Tissue Engineering, School of Advanced Technologies, Shahrekord University of Medical Sciences, Shahrekord, Iran Zahra Namazi zahra.t.namazi@gmail.com 10031947532846005134 10031947532846005134 No Department of Dental Biomaterials, School of Dentistry, Shahid Beheshti Univeristy of Medical Sciences, Tehran, Iran