This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.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 internal fixation of fractures in the radius, ulna, humerus, clavicle, and distal fibula with the variax 2 compression plating system¿ which is associated with the stryker ¿variax 2 compression plating¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from may 2015 - august 2018.It was not possible to ascertain specific 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 15 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses nonunion associated with plate loosening followed by revision of fixation left humerus with autograft from femur and a wide plate.The report states: ¿she had single fracture fixation, the plate used was narrow straight with 10 holes and 6 screws.Patient showed progressive healing throughout the first year of treatment but no full consolidation.She was diagnosed with nonunion 591 days after surgery and associated with loosening of the fixation plate.A revision after nonunion fracture was diagnosed, revision of fixation left humerus with autograft from femur and a wide plate was used for the procedure.An x ray performed 87 days post revision surgery showed no significant interval healing.Patient did not have further follow up, (total follow up time is 704 days since first surgery).¿.
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