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 pmcf from (b)(6), united states.The title of this report is ¿a retrospective data collection of the treatment of upper and lower extremity fractures with the t2 kids flexible nailing system.¿ which is associated with the stryker ¿t2 kids flexible nailing¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2012 to 2017.It was not possible to ascertain specific patient & 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 9 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses prominent nail trimming.2 out of 2 cases.The report states: ¿1/66 (15%) patients required prominent nail trimming twice.¿.
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