The manufacturer became aware of a post market clinical follow-up (pmcf) from university hospital (b)(6).The title of this report is ¿a post-market clinical follow-up of the treatment of clavicle fractures and ac joint injuries with the variax clavicle locking plate system¿ which was published in january 2019 and is associated with stryker variax clavicle locking plate system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1st january 2012 to 31st december 2017.It was not possible to ascertain specific device from the article; 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, 12 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses loss of reduction, revision surgery.The study states: "a (b)(6) man slipped while carrying furniture in (b)(6) 2013 and fell on his right shoulder.He contracted a lateral clavicle fracture which was treated with a lateral hook plate.The secondary diagnoses are chronic renal insufficiency in cystic kidneys, systolic dysfunction, diastolic dysfunction and mild concentric hypertrophy.The patient has neither osteoporosis nor diabetes and whether he smokes is not known.Initial surgery was performed without complications in (b)(6) 2013.After the osteosynthesis failure had been diagnosed (after 45 days), a material removal was performed at the end of (b)(6) 2013, followed by a new restoration with a new plate.In (b)(6) 2014 (237 days after the second restoration was inserted), the material was removed from the healed clavicle.
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