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 städtisches klinikum dresden, in germany.The title of this report is ¿reduced complication rates for unstable trochanteric fractures managed with third-generation nails: gamma 3 nail versus pfna¿ which is associated with the stryker ¿gamma3 nailing¿ system.Article can be found on https://doi.Org/10.1007/s00068-019-01200-7.This report includes research done on 53 patients between the period from july 2005 to dec 2006.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 (4) cases of hematoma or wound dehiscence followed by reoperation.
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