Chinese Journal of Pharmacovigilance ›› 2010, Vol. 7 ›› Issue (3): 172-174.
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WANG Hong, YANG Li-jun, DENG Jian-xiong, XING Xin, LIN Guo-liang, LU Shu-tang
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Abstract: Objective To investigate some of the hospitals in Guangdong Province of cases involving orthopedic im-plants, concluded the incidence of administration events and characteristics. Methods seven hospitals in Guangdong Province related to orthopedic implants screening of all cases in 2008, the discovery of the 126 cases of suspected adverse events for statistical analysis. Results The incidence of the administration events of the orthopedic implants was 5.87%, which was much higher in the second admitted cases(16.51%) than in the first(2.43%). The administration events incidence of the spinal internal fixation was higher, the others were without statistical difference. The fracture, the loosen, the distortion and the infection were the most familiar manifestation(69%), the material ant the designing factors of the implants were the main causes of the administration events(72.22%). Conclusion There is a large number of omissions phenomenon in clinical administration events of orthopedic implants,, which need to strengthen orthopedic implants, adverse event monitoring.
Key words: Medical Device Administration Events(MDAE), orthopedic implants, analyze, pro-active monitoring
CLC Number:
R955
WANG Hong, YANG Li-jun, DENG Jian-xiong, XING Xin, LIN Guo-liang, LU Shu-tang. Investigating and Analyzing the Orthopedic Implants Administration Events in Guangdong Province[J]. Chinese Journal of Pharmacovigilance, 2010, 7(3): 172-174.
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