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 conducted by (b)(6) hospital in (b)(6).The title of this report is ¿a retrospective data collection of the treatment of humeral fractures with the t2 humeral nailing system¿ which is associated with the stryker ¿t2 humeral nailing¿ system.This report includes research done on 95 patients from the period january 2011 to april 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 non-union resulting in permanent disability.The report states: there was no bone consolidation within 6 months.Patient presented significant loss of mobility, but the patient refused a new surgical intervention.
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