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.
|
The manufacturer became aware of a study from (b)(6) university hospital, (b)(6).The title of this report is ¿static monolateral external fixation for the rolando fracture: a simple solution for a complex fracture¿ which is associated with the stryker ¿hoffmann 2 external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from january 2003 to december 2009.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 3 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses superficial infection.1 out of 3 cases.The report states: ¿three of the eight cases were complicated by superficial pin site infection (based on clinical diagnosis at follow up in fracture clinic) and successfully treated with oral flucloxacillin.Early removal of the external fixator was required in only one case because the infection was considered significant enough to risk deep infection;¿.
|