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.
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The manufacturer became aware of a pmcf published by klinikum aschaffenburg ¿ alzenau, in germany.The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of hand and wrist fractures with the stryker hand plating system¿ which is associated with the stryker ¿ variax hand locking and profyle standard¿ system.This report includes research done on 105 patients between the period may, 2019 and april, 2020.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 (8) cases of adhesion of tendon followed by revision surgery.
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