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.Device disposition is unknown.
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The manufacturer became aware of a literature published by department of traumatology, orthopaedics & reconstructive surgery, clinic bayreuth in germany.The title of this report is ¿complications in treatment of 31-a fractures with trochanteric gamma nail (tgn) versus gamma3 nail (g3n) - a review of 217 cases¿ published on august 10, 2016, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at doi: 10.2174/1874325001610010389.This report includes research done on 217 patients between the period april 2010 and april 2011.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 pulmonary oedema.
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