This complaint has been reported during a literature review performed by the post market surveillance group.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 pmcf from university hospital (b)(6).The title of this report is ¿a post-market clinical follow-up of the treatment of elbow fractures with the variax elbow locking plate system¿ which is associated with the stryker ¿variax elbow locking plate¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 01/01/2012 to 31/12/2017.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 21 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses screw backout followed by it's removal.The report states: ¿woman, (b)(6) years old, bmi 23, fell in her apartment and had contracted a dislocated supracondylar humerus fracture on the right.This was treated with a stryker variax double osteosynthesis.The patient is a non-smoker and has no osteoporosis but a diabetes mellitus.Atrial fibrillation, aortic valve stenosis, mitral valve and tricuspid valve insufficiency are known as secondary diagnoses.In the course of the disease a dislocation of an inserted ulnar screw developed.These were removed in a second operation and in addition an external fixator was applied.The healing process was regular and the patient was discharged for geriatric followup treatment.After 4 months the patient was admitted again for removal of the fixator.After 9 months bony consolidation and regular wound conditions.¿.
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