STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number UNK_KIE |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/26/2021 |
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 cut out of the medial cortex of the calcaneum, 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.Device not available.
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Event Description
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The manufacturer became aware of a literature published by (b)(6) hospital, (b)(6).The title of this report is ¿¿a comparison of fibula pro-tibia fixation versus hindfoot nailing for unstable fractures of the ankle in those older than 60 years,¿ published on (b)(6) 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail.¿ the article can be found at doi: https://doi.Org/10.1177/19386400211017373.This report includes analysis of the clinical data that was collected on 68 patients, and the cases in this study range from (b)(6) 2012 to (b)(6) 2018.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 1 patient experienced early cut out of the medial cortex of the calcaneum, requiring revision.The report states, ¿in the case of surgical placement error, the calcaneal entry point was placed too medially resulting in early cut out of the medial cortex of the calcaneum on the postoperative radiographs.¿.
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