The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.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.Based on the available information, no relation could be established between the device and the reported event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device evaluated by mfr: device disposition is unknown.
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The manufacturer became aware of a study from (b)(6) university, (b)(6).The title of this report is ¿open reduction and low-profile plate and/or screw fixation in the treatment of phalangeal fractures¿ which was published in march 2009 and is associated with the stryker variax hand plating system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2001 to 2007.In the provided study, products from two manufacturers, one of them being stryker, were used.It cannot be determined whether the reported adverse events are related to stryker products.It was not possible to ascertain specific device or patient information from the study; 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, 13 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses joint stiffness and permanent swelling.7 out of 7 cases.The study reports: ¿in 11 fractures (61,1%), at least one or more complications were seen.[.] joint stiffness causing difficulty of use and permanent swelling around the surgery area in 7 fingers (38,8%).[.] 7 major (tarm<180°; 38,8%) and 6 minor (tarm between 180 and 195° in 4 patients and delayed union in 2 patients; 33,3%) complications were identified.Major complications occurred in 3 (27,2%) of the 11 fingers fixed with screws, and in 4 (%57,1) of the 11 fingers which received plate screw fixation.[.] the most common complication in our study was finger stiffness which mostly accompanied permanent swelling.In 7 of the 18 fingers studied (38,8%), tarm was below 180°.¿.
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