STRYKER TRAUMA KIEL UNKNOWN T2 TIBIAL 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 11/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of nonunion, requiring revision, 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.
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Event Description
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The manufacturer became aware of a literature published by the ¿department of orthopaedics and trauma, the royal infirmary of edinburgh, uk¿.The title of this report is, ¿application of the radiographic union scale for tibial fractures (rust): assessment of healing rate and time of tibial fractures managed with intramedullary nailing¿, published on november 27, 2019, which is associated with the stryker ¿t2 tibia nailing system¿.The article can be found at https://doi.Org/10.1016/j.Otsr.2019.10.010.This report includes an analysis of the clinical data that was collected on 217 patients.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 16 patients experienced non-union, which required revisions: 11 patients underwent exchange intramedullary (im) nailing.4 patients had their im nails removed and an ilizarov frame applied.1 patient underwent a below-knee amputation.
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Manufacturer Narrative
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H1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.Link to the published article: the article can be found at https://doi.Org/10.1016/j.Otsr.2019.10.010.
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Event Description
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The manufacturer became aware of a literature published by the ¿department of orthopaedics and trauma, the royal infirmary of edinburgh, uk¿.The title of this report is, ¿application of the radiographic union scale for tibial fractures (rust): assessment of healing rate and time of tibial fractures managed with intramedullary nailing¿, published on november 27, 2019, which is associated with the stryker ¿t2 tibia nailing system¿.This report includes an analysis of the clinical data that was collected on 217 patients.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 16 patients experienced non-union, which required revisions: 11 patients underwent exchange intramedullary (im) nailing.4 patients had their im nails removed and an ilizarov frame applied.1 patient underwent a below-knee amputation.The article can be found at https://doi.Org/10.1016/j.Otsr.2019.10.010.
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