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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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A total of 58 patients (27 males and 31 females) with a mean age of 70 years (range, 16-94 years) were included in the study.510k: this report is for an unknown dcs construct/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.[(b)(4)].
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Event Description
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This report is being filed after the review of the following journal article: sushrut s.Kulkarni and christopher g.Moran (2003), results of dynamic condylar screw for subtrochanteric fractures, injury-international journal of the care of the injured vol.34(n), pages 117-122 (united kingdom).The aim of this article is to review the results of treating subtrochanteric fractures using the dcs and identify important factors that influence the outcome.Between 1990-1997, a total of 58 patients (27 males and 31 females) with a mean age of 70 years (range, 16-94 years) were included in the study.These patients were treated with dynamic condylar screw (dcs) for subtrochanteric fractures.The mean duration of follow-up was 8 months.The following complications were reported as follows: intraoperative problem was noted such as excessive bleeding.Additional complications are captured on related complaint (b)(4).This report is for an unknown dcs construct.This is report 8 of 9 for (b)(4).
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Search Alerts/Recalls
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