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 study from (b)(6).The title of this report is ¿operative treatments compared with nonoperative treatment of displaced midshaft clavicular fractures¿ which is associated with the stryker apex system and plating system.Within that publication, post-operative complications/ adverse events were reported which occurred between march 2012 and may 2015.It was not possible to ascertain specific device lot or patient information 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 28 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses pin infection.4 out of 4 cases.The report states, ¿for the external fixation group, as the biggest complication, pin infection was treated with antibiotics and local wound care.All patients were eventually cured.¿.
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