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Catalog Number UNK_KIE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non-union Bone Fracture (2369); Impaired Healing (2378)
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Event Date 07/14/2022 |
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 delayed union, which required 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.Device disposition unknown.
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Event Description
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The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (gt) of the t2 alpha femur antegrade gt/pf nailing system¿.The study was conducted at ¿bg unfallklinik murnau, germany'.The report is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿ and includes an analysis of the clinical data that was collected on 22 patients.The cases in the study range from november 2019 and june 2021.Event #2 of 2.The report indicates that one (1) patient continued to experience delayed union, which required further revision surgery.The report states, ¿t2 gtn was inserted.After one month also this nail was changed.Follow-up regarding bone healing is not available¿.
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Manufacturer Narrative
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Please note correction to clinical code.
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Event Description
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The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (gt) of the t2 alpha femur antegrade gt/pf nailing system¿.The study was conducted at ¿bg unfallklinik murnau, germany'.The report is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿ and includes an analysis of the clinical data that was collected on 22 patients.The cases in the study range from november 2019 and june 2021.Event #2 of 2.The report indicates that one (1) patient continued to experience delayed union, which required further revision surgery.The report states, ¿(.) t2 gtn was inserted.After one month also this nail was changed.Follow-up regarding bone healing is not available¿.
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Search Alerts/Recalls
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