This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device disposition is unknown.
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The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post market clinical follow-up (pmcf) of the treatment of hand and wrist fractures with the stryker hand plating system¿ which was published in june-2019 and is associated with the 'stryker variax hand 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 catalog 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 37 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses malposition of the plate.1 out of 2 cases.The report states, ¿man, (b)(6) years old, bmi 27.9 has squeezed himself digitus 3-digitus 4 as part of his professional activity.The patient has no secondary illnesses.The patient is a non-smoker and has no osteoporosis or diabetes.After two months, the patient had already carried too heavy again too early and contracted a malposition of the plate.This was determined in a routine follow-up examination.The patient didn't want another surgery.The complete consolidation with good functionality was documented after 6 months.¿.
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