This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.
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The manufacturer became aware of a study from st.Cloud orthopedics, mn, united states.The title of this report is ¿enhanced cephalomedullary nail lag screw placement and intraoperative tip-apex distance measurement with a novel computer assisted surgery system¿ and is associated with the stryker adapt & gamma nailing system which was published on october 2016.Within that publication, post-operative complications/ adverse events were reported occurred from 1-september- 2011 to 2-april-2014.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 18 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses patient death.1 out of 14 cases.The cause and the date of the death is unknown and will not be disclosed.
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