STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 LAG SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number UNK_KIE |
Device Problems
Malposition of Device (2616); Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/30/2016 |
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 regarding the superior position of the lag screw 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 ¿department of orthopedics, the affiliated hospital of qingdao university, china¿.The title of this report is, ¿a randomized prospective comparison of intertan and gamma3 for treating unstable intertrochanteric fractures¿, published on may 30, 2016, which is associated with the stryker ¿gamma-3 nailing system¿.This report includes an analysis of the clinical data that was collected on 126 patients, and the cases in this study range from january 2011 to august 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 superior position of lag screw.
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Event Description
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The manufacturer became aware of a literature published by the ¿department of orthopedics, the affiliated hospital of qingdao university, china¿.The title of this report is, ¿a randomized prospective comparison of intertan and gamma3 for treating unstable intertrochanteric fractures¿, published on may 30, 2016, which is associated with the stryker ¿gamma-3 nailing system¿.The article can be found at https://e-century.Us/files/ijcem/9/5/ijcem0019996.Pdf.This report includes an analysis of the clinical data that was collected on 126 patients, and the cases in this study range from january 2011 to august 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 superior position of lag screw.
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Manufacturer Narrative
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Please note corrected data to event description (b5).Correction: please refer to h6 device code.
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Search Alerts/Recalls
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