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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/08/2018 |
Event Type
Injury
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Event Description
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This report is being filed after the review of the following journal article: li, y.Et al (2018), treatment of humeral intramedullary fractures with internal turning plates: clinical effects of locking plates and intramedullary nails (china).The aim of this retrospective study is to evaluate the clinical efficacy of philos locking plate and multiloc intramedullary nail in the treatment of 2-part and 3-part fractures of the humerus.Between february 2014 to june 2016, a total of 25 patients were included in the study.Among these, 12 patients (6 male and 6 female; mean age of 58.20 ± 5.88 years) were treated with philos locking plate (locking plate group) and 13 patients (8 male and 5 female; mean age of 58.27 ± 8.82 years) were treated with multiloc intramedullary nail (intramedullary nail group).All patients were followed up for 12-24 months.The following complications were reported as follows: philos group: 3 patients had mild pain after surgery, and all had pain relief after oral administration of seloxifene.Multiloc nail group: 2 patients had mild pain after surgery, and all had pain relief after oral administration of seloxifene.This report is for an unk - construct: multiloc humeral nail.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Additional narrative: 510k: this report is for an unknown construct: multiloc humeral nail/unknown lot.Part and lot numbers 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.
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Search Alerts/Recalls
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