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.
|
The manufacturer became aware of a post-market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a retrospective data collection treatment of elbow fractures with the variax elbow plating system¿ which is associated with the 'stryker variax elbow locking plating system'.Within that publication, post-operative complications/ adverse events were reported which occurred between january 2011 to december 2018.It was not possible to ascertain specific device 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 9 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses wound drainage and irrigation and debridement and removal of the lateral column plate.The pmcf states, ¿one patient suffered a wound complication resulting in exposed hardware requiring multiple irrigation and debridements and eventual removal of hardware.Of note, the patient suffers from dementia.[¿] the patient subsequently developed wound drainage and was taken back for irrigation and debridement and removal of the lateral column plate two months after the previous irrigation and debridement and removal of medial column plate.The patient went on to have an uneventful recovery and was able to achieve both clinical and bony consolidation approximately four months after the index procedure.¿.
|