The manufacturer became aware of a literature published by the ¿department of trauma-, hand- and reconstructive surgery, university hospital jena, germany¿.The title of this report is "the anterior intrapelvic approach for acetabular fractures using approach-specific instruments and an anatomical-preshaped 3-dimensional suprapectineal plate", published on july 01, 2017, and can be found at doi: 10.1097/bot.0000000000000829.The report is associated with the stryker ¿pro plating system' and includes an analysis of the clinical data that was collected on 30 patients.The cases in this study range from january 2014 to december 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 nerve lesions.The report states, ¿three nerve lesions (2 obturator nerve, 1 lateral femoral cutaneous nerve) were observed.Although 1 obturator nerve lesion recovered completely at 6 months follow-up, one patient still suffered from adductor muscle weakness.The lateral femoral cutaneous nerve lesion was improving, but still present at 1- year follow-up¿.
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This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of trauma-, hand- and reconstructive surgery, university hospital jena, germany ¿.The article can be found at doi: 10.1097/bot.0000000000000829. 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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