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 (b)(6).The title of this report is ¿the use of external fixators in the definitive stabilisation of the pelvis in polytrauma patients: safety, efficacy and clinical outcomes¿ which is associated with the stryker ¿hoffman ii external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from march 2007 to december 2012.It was not possible to ascertain specific device/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 38 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses septic shock attributed to pin site infection followed by revision.The report states: ¿one patient presented with septic shock that was attributed to pin site infection 30 days after the application of a pef.He required admission to the intensive care unit, removal of the pef, surgical debridement of the pin sites and administration of intravenous antibiotics.¿.
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