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 complejo hospitalariode palencia, in spain.The title of this report is ¿comparative study of the second and third generation of gamma nail for trochanteric fractures: review of 218 cases¿ which is associated with the stryker ¿gamma nailing¿ system.The article can be found with pubmed id 24983431.Within that publication which included 218 cases, post-operative complications were reported, which allegedly occurred from january 2005 and december 2010.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 cutout.
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