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

Abstract

Background and AimCranfixer 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/PatientsCranfixer 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. Inaddition, a retrospective review was performed about the reason of surgery.ResultsFlap 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).ConclusionThe 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.