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 literature published by department of orthopaedic surgery, kokuho central hospital, tawaramoto in japan.The title of this report is ¿clinical outcomes of unstable metacarpal and phalangeal fractures treated with a locking plate system: a prospective study¿ published on january 20, 2020, which is associated with the stryker ¿variax plating¿ system.The article can be found at https://doi.Org/10.1177/1753193419899332.This report includes research done on 34 patients between the period october, 2011 and december, 2016.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 10 cases of postoperative finger stiffness at the time of final follow-up.
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