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 dislocation followed by revision.The report states: ¿woman, (b)(6) years old, bmi 28.7, fell out of bed and had contracted a supracondylar humerus fracture on the left.This was treated with a stryker variax double osteosynthesis.The patient is non-smoker and has no osteoporosis but has diabetes mellitus, hypertension, obesity, peripheral arterial occlusion disease, lower leg amputation with wound healing disorder, renal insufficiency, cardiomyopathy, coronary heart disease with stent insertion, urinary incontinence, atrial fibrillation, arteriosclerotic encephalopathy, depressive moods and dementia.In the course of the hospital stay, the arm was overloaded.After 4 months the dislocation of the fracture was diagnosed and a revision operation was performed.Documentation of the healing after 8 months.¿.
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