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 evaluated by mfr: device disposition is unknown.
|
The manufacturer became aware of a post-market clinical follow-up (pmcf) from university hospitals (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the internal fracture fixation of long bones with the stryker plating system (sps)¿ which was published in june 2019 and is associated with the stryker plating system (sps).Within that publication, post-operative complications/ adverse events were reported which occurred between july 2014 to july 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, 22 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses prominence of metalwork.1 out of 4 cases.The pmcf report states, ¿t-plate applied to medial malleolus of the tibia in a complex multi trauma subject who required a contralateral amputation, subject is discharged but plates remain in situ, they are prominent affecting the soft tissues but because of a soft tissue flap reconstruction they are planned to be left in.The fractures are united.[¿] prominence of metalwork is in the authors experience often more likely due to patient factors than the design of the plate¿.
|