The manufacturer became aware of a literature published by the ¿department of orthopaedic trauma, nanfang hospital, southern medical university¿.The title of this report is ¿percutaneous screw fixation of crescent fracture-dislocation of the sacroiliac joint¿, published on october 20, 2015, and can be found at doi: 10.3928/01477447-20151020-05.The report is associated with the stryker ¿pro system¿ and includes an analysis of the clinical data that was collected on 117 patients.The cases in this range from july 2003 and july 2013.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 3 patients experienced iatrogenic neurologic injuries.
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This record is a consolidation of events summarized as part of literature review when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event regarding the iatrogenic neurologic injuries 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.
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