STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS 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
Nerve Damage (1979)
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Event Date 02/01/2021 |
Event Type
Injury
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Event Description
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The manufacturer became aware of a literature published by diakonhjemmet hospital, oslo, norway.The title of this report is ¿retrograde nailing, trabecular metal implant and use of bone marrow aspirate concentrate after failed ankle joint replacement ¿, published on february 01, 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail¿.The article can be found at https://doi.Org/10.1016/j.Fas.2020.03.003.This report includes analysis of the clinical data that was collected on 30 patients, and the cases in this study range from january 2016 to february 2019.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 2 patients experienced an injury to the medial plantar nerve or the tibial nerve.
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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 injury to the medial plantar nerve or the tibial nerve 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 diakonhjemmet hospital, oslo, norway.The title of this report is ¿retrograde nailing, trabecular metal implant and use of bone marrow aspirate concentrate after failed ankle joint replacement ¿, published on february 01, 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail¿.The article can be found at https://doi.Org/10.1016/j.Fas.2020.03.003.This report includes analysis of the clinical data that was collected on 30 patients, and the cases in this study range from january 2016 to february 2019.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 2 patients experienced an injury to the medial plantar nerve or the tibial nerve.
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Manufacturer Narrative
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Please note correction to section.
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