Two of 4 reports: the foot and ankle international journal (2017) published ¿comparison of posterior approach with intramedullary nailing versus lateral transfibular approach with fixed-angle plating for tibiotalocalcaneal arthrodesis¿.The purpose of this study was to compare the results of tibiotalocalcaneal (ttc) arthrodesis with either a posterior, achilles tendon-splitting (pats) approach with intramedullary (im) nailing or lateral, transfibular (ltf) approach with fixed-angle plating.Sixty-six patients were identified, thirty-eight underwent ttc arthrodesis through a pats approach with im nailing and 28 underwent the same procedure through an ltf approach and fixed-ankle plating.Four patients had superficial wound breakdown and cellulitis that cleared with local wound care and oral antibiotics.Additional information was requested to the author.However, no further information is available.
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The device was not returned for evaluation.As no product id and no manufacturing lot number was provided to integra, no device history record (dhr), design specification or design change record will be performed.A review of the current instruction for use was performed.In conclusion, preoperative risk factors and etiology of this group are mentioned in ifu.Also, as product was not returned, no failure analysis was performed.The root cause is not determined but, physical condition, preoperative risk factors and etiologies of the patients might be reason of infection.Moreover, there is a low risk that the packaging of products involved in these incidents did not provide the level of sterility intended.
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