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 pmcf report from (b)(6) university hospitals, (b)(6).The title of this report is ¿a retrospective cohort study of fractures treated with the variax distal radius locking plate system¿ which is associated with the stryker variax distal radius locking plate system.Within that publication, post-operative complications/ adverse events were reported which occurred between 19-may-2014 and 28 march 2018.It was not possible to ascertain specific patient or device catalog information from the study, 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 25 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses protrusion of screws into articular space causing reduced rom.Removal of metalwork.
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