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Catalog Number UNKNOWN |
Device Problem
Insufficient Information (3190)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 07/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Doi: 10.1016/j.Injury.2019.07.023.
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Event Description
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It was reported that on literature review "early clinical and radiographic outcomes of a mini-fragment, low profile plating system in tibial plafond fractures", 2 patients had a hardware failure with bony nonunion after a tibial plafond fracture treatment procedure using a mini-evos plating system.The events were resolve by performing an additional surgery.Patients outcome are unknown.No further information is available.
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Search Alerts/Recalls
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