This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a study from trauma center (b)(6).The title of this report is "outcome analysis of retrograde nailing and less invasive stabilization system in distal femoral: a retrospective analysis" which is associated with the ¿stryker t2 nailing system'.Within that publication, post-operative complications/ adverse events were reported which occurred between january-2003 and december-2008.It was not possible to ascertain specific device or patient details from the report, 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 43 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses removal of symptomatic hardware.31 out of 36 cases.The report states: "indication for removal of retrograde i.M.Nail was the symptomatic hardware.The retrograde i.M.Nail had been removed in 36 patients till now.".
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