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) hospital, (b)(6).The title of this report is ¿treatment of distal tibial shaft fractures by three different surgical methods: a randomized, prospective study¿ which is associated with the stryker ¿hoffman ii external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from november 2002 to june 2012 and which was published on 19 february 2014.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 15 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses inflammation followed by revision.Revision surgery for inflammatory foreign body reaction.2 out of 3 cases.The report states: ¿in group c, no deep infection and nonunion developed, and three others received secondary operations for inflammatory foreign-body reaction.¿.
|