This report is for an unknown nails: multiloc humeral/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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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This report is being filed after the review of the following journal article: dauwe, j.Et al.(2020).Osteosynthesis of proximal humeral fractures: a 1-year analysis of failure in a belgian level-1 trauma centre, european journal of trauma and emergency surgery, vol.Xx, page xx (belgium).The aim of this study was to perform a retrospective patient record analysis over 1 year to calculate the failure rate at the university hospitals of leuven, a belgian level-1 trauma centre.Furthermore, different (fracture unrelated) variables were taken into account to predict the failure of osteosynthesis after phf.From january 2017 to january 2018, a total of 134 patients (47 males and 87 females) were treated with angular stable osteosynthesis using a philos plate (ao synthes gmbh, oberdorf, switzerland), an alps plate, zimmer-biomet, warsaw, usa) and a multiloc proximal humeral nail (ao synthes gmbh, oberdorf, switzerland).The following complications were reported as follows: 21 cases of the proximal humeral osteosynthesis failed.6 patients needed a reoperation because of non-union.4 patients had to be revised because of infection.11 patients were revised because of other causes.(loosening or breakage of the implant, screw pull-out and screw penetration.) this report is for a unknown multicloc proximal humeral nail.This is report 4 of 5 for (b)(4).
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