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 study from a.(b)(6).The title of this report is ¿the external fixation in the treatment of humeral diaphyseal fractures: outcomes of 84 cases¿ which is associated with the stryker ¿hoffman ii external fixator¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from august 1995 to march 2007.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 12 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses loss of reduction followed by revision.The report states: ¿in a single case it was necessary to reapply the frame at the second post-operative day due to loss of achieved reduction after a crisis to a psychiatric patient.¿.
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