STRYKER TRAUMA KIEL 11*380 T2 ALPHA FEMORAL NAIL PF RIGHT; 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 12/13/2021 |
Event Type
Injury
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Event Description
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The manufacturer became aware of a pmcf final study report that was conducted by university of louisville in the usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (pf) of the t2 alpha femur antegrade gt/pf nailing, which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing¿ system.This report includes analysis of the clinical data that was collected on 28 patients, the cases in this study range from march 2019 through august 2020.During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available.It was reported that one patient experienced nonunion which required revision surgery.The report states: ¿patient i (1 device related event): the 3rd nonunion case was (b)(6) male, bmi 27.1, smoker, diabetic, with copd and asthma.His injury was due to mva and was classified as closed 32-b2 fracture.The devise used for the initial fixation surgery was 11*380 t2 alpha femoral nail pf right, with recon locking mode.The nonunion was diagnosed 185 days post initial surgery and had a revision surgery 13mm gamma nail which resulted healing 117 days post revision surgery.¿.
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Manufacturer Narrative
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This complaint has been generated based on findings discovered during post market surveillance pmcf study review.The alleged nonunion which required revision surgery included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available.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 is unknown.
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Manufacturer Narrative
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This complaint has been generated based on findings discovered during post market surveillance pmcf study review.The alleged nonunion which required revision surgery included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available.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 is unknown.
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Event Description
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The manufacturer became aware of a pmcf final study report that was conducted by university of louisville in the usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (pf) of the t2 alpha femur antegrade gt/pf nailing, which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing¿ system.This report includes analysis of the clinical data that was collected on 28 patients, the cases in this study range from march 2019 through august 2020.During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available.It was reported that one patient experienced nonunion which required revision surgery.The report states: ¿patient i (1 device related event): the 3rd nonunion case was (b)(6) male, bmi 27.1, smoker, diabetic, with copd and asthma.His injury was due to mva and was classified as closed 32-b2 fracture.The devise used for the initial fixation surgery was 11*380 t2 alpha femoral nail pf right, with recon locking mode.The nonunion was diagnosed 185 days post initial surgery and had a revision surgery 13mm gamma nail which resulted healing 117 days post revision surgery.¿.
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