STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number UNK_KIE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 12/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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This record is a consolidation of events summarized as part of literature review when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of poor reduction, which required dynamization, 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 medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.
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Event Description
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The manufacturer became aware of a literature published by the ¿altnagelvin area hospital, uk¿.The title of this report is ¿a review of atypical subtrochanteric femoral fractures in northern ireland between 2010 and 2014 ¿, published on december 22, 2017, which is associated with the stryker ¿gamma 3 nailing system¿.The article can be found at https://doi.Org/10.1007/s00590-017-2113-7.This report includes an analysis of the clinical data that was collected on 26 patients.The cases in this study range from january 2010 to december 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 2 patients experienced poor reduction, which required dynamization.The report states ¿¿two required minor procedure to dynamize their cephalomedullary nail.¿¿.
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