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 literature from hopital antoine beclere, france.The title of this report is ¿external fixation of the thalamic portion of a fractured calcaneus: a new surgical technique¿ which is associated with the stryker ¿hoffmann external fixaton¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 1997 to 2011.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 5 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses need of bone substitute.1 out of 2 cases.The report states: ¿bone substitute was needed in only two cases.¿.
|