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 pmcf from (b)(6).The title of this report is ¿a retrospective data collection of the treatment of femur fractures with the t2 femoral nailing system¿ which is associated with the stryker ¿t2 femoral nailing¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 1/2014 to 12/2018.It was not possible to ascertain specific device 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 42 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses delayed healing followed by dynamisation of the nail by removal of 2 proximal screws.The report states: ¿a (b)(6) year old caucasian male (#47) with polytrauma due to a traffic accident received t2femur nail.After 5 month delayed healing was found.Dynamisation of the nail by removal of 2 proximal screws was performed.Consolidation was radiologically confirmed in a follow-up visit two years after initial surgery.¿.
|