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 conducted by the institution orthoneuro in usa.The title of this report is ¿a retrospective data collection of the fixation and stabilization of small and long bones with the fixos screw system¿ which is associated with the stryker ¿fixos® forefoot & midfoot screw system¿ system.This report includes research done on 24 patients between the period 2018 and 2019.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses pulmonary embolism.The report states the next reported ae (adverse event) was due to a pulmonary embolism a participant experienced 25 days after surgery.No revision surgery was required, and this event did not result in permanent disability or death and is now resolved.This patient had 1 screw implanted.
|