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 of angular defects 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 disposition unknown.
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The manufacturer became aware of a literature published by the ¿orthopaedic department, university of pisa, italy ¿.The title of this report is ¿the role of external fixation in the treatment of humeral shaft fractures: a retrospective case study review on 85 humeral fractures ¿, published on september 16, 2014.Which is associated with the stryker ¿hoffman ii external fixation system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.08.045.This report includes an analysis of the clinical data that was collected on 85 patients.The cases in this study range from 2001 to 2010.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 5 patients experienced angular defects between 10 degrees and 20 degrees.
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