This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of trauma and orthopaedic surgery, university medical center hamburg-eppendorf, germany¿.The article can be found at https://doi.Org/10.1007/s00402-021-03867-3. the reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author. more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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The manufacturer became aware of a literature published by the ¿department of trauma and orthopaedic surgery, university medical center hamburg-eppendorf, germany¿.The title of this report is ¿the influence of bone quality on radiological outcome in 50 consecutive acetabular fractures treated with a pre-contoured anatomic suprapectineal plate¿, published on march 24, 2021, and can be found at https://doi.Org/10.1007/s00402-021-03867-3.The report is associated with the stryker ¿¿pro plating system¿ and includes an analysis of the clinical data that was collected on 50 patients.The cases in this study range from 2015 to 2020.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 1 patient experienced an intraoperative injury to the internal iliac vein, which required primary repair and blood transfusions.
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