Risk analysis and implants.
According to the Medical Devices Directive, both the preparation for clinical trials and marketing of implants require that a risk analysis is performed. This paper presents a risk analysis for a dental implant in the framework of the risk management process carried out for the preparation of a multi-centre clinical trial, where likely hazards, failure modes and their severities, probabilities and detectabilities are assessed, together with a review of the related scientific literature. The clinical study aimed to evaluate a new ion implantation-based implant surface designed for the promotion of more extensive and faster osseointegration.
Inasmet-Tecnalia, San Sebastian, Spain. ibracera@inasmet.es
I
I
Braceras
E
E
Ipiñazar
M A
MA
De Maeztu
J I
JI
Alava
D015921:Dental Implants / Q000706:statistics & numerical data*; D017268:Dental Prosthesis Retention / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D010518:Periodontitis / Q000453:epidemiology*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D016016:Proportional Hazards Models; D016459:Prosthesis-Related Infections / Q000453:epidemiology*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology; D016896:Treatment Outcome
D015921:Dental Implants