The manufacturer became aware of a literature published by (b)(6) hospital, (b)(6).The title of this report is ¿¿a comparison of fibula pro-tibia fixation versus hindfoot nailing for unstable fractures of the ankle in those older than 60 years,¿ published on (b)(6) 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail.¿ the article can be found at doi: https://doi.Org/10.1177/19386400211017373.This report includes analysis of the clinical data that was collected on 68 patients, and the cases in this study range from (b)(6) 2012 to (b)(6) 2018.During the review of the literature, it was not possible to establish a specific device detail, and patient information, and at this time no additional device information is available.It was reported that 7 patients experienced nonunion: it was reported that 5 patients experienced painful nonunion, requiring revision.It was reported that 2 patients experienced nonunion.
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged nonunion could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device not available.
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