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, de… Show more
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