Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer
| Autor: | Zahra Namazi, Hosein Esmaili Dezaki, Seyed Roholah Ghodsi, Morteza Alizadeh |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Retrospective review skull business.industry medicine.medical_treatment lcsh:Surgery Postmarketing surveillance lcsh:RD1-811 cranfixer postmarketing Surgery internal fixators lcsh:RC321-571 Food and drug administration Skull medicine.anatomical_structure burrhole cover medicine Ct imaging business lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry Craniotomy Fixation (histology) product surveillance |
| Zdroj: | Iranian Journal of Neurosurgery, Vol 5, Iss 2, Pp 54-62 (2019) |
| ISSN: | 2423-6497 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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