The manufacturer became aware of a literature published by the ¿university hospital southampton nhs foundation trust, uk ¿.The title of this report is ¿operative treatment of calcaneal fractures: improved outcomes and low complications rates with a strict management protocol ¿, published on august 11, 2016, and can be found at doi 10.1308/rcsann.2016.0259.The report is associated with the stryker ¿sps small fragment plating system¿ and includes an analysis of the clinical data that was collected on 80 patients.The cases in this range from 2005 and 2014.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 screw prominence in the subtalar joint, which required a repeat procedure.
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This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿university hospital southampton nhs foundation trust, uk ¿.The article can be found at doi 10.1308/rcsann.2016.0259.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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