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 literature published by orthopaedic department, general hospital of trikala in greece.The title of this report is ¿treatment of humeral shaft fractures with antegrade intramedullary locking nail¿ published on april 5, 2011, which is associated with the stryker ¿t2 humeral nailing¿ system.The article can be found at doi 10.1007/s12306-011-0126-7.This report includes research done on 52 patients between the period 2005 and 2008.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 a case of superficial infection at the insertion point, which healed after surgical debridement and antibiotic therapy.
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