510k: this report is for an unknown synthes proximal humeral internal locking system (philos) plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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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This report is being filed after the review of the following journal article: rollo, g.Et al (2017), grafting and fixation of proximal humeral aseptic non-union: a prospective case series, clinical cases in mineral and bone metabolism, vol.14(3), pages 298-304 (italy).The purpose of this prospective study is to evaluate the outcomes of the plate opposed to a strut allograft with morsellised bone graft in the management of aseptic non-union of the proximal humerus.Between january 2008 and september 2016, a total of 16 patients (6 male and 8 female) with a mean age of 62.3 years (range, 55-70 years) underwent medial humeral shaft bone strut allograft and lateral plate and screws with bone chips grafting using proximal humeral internal locking system (philos) plate (synthes, oberdorf, switzerland).The follow-up was performed with clinical and radiographic controls at 1 month, 3 months, 6 months, and 12 months and annually thereafter.The evaluation endpoint was set at 12 months.The mean follow-up was 32 months (range, 12-96 months).The following complications were reported as follow: a (b)(6) patient had an aseptic non-union of proximal humeral with phenomena of avascular necrosis of the head.16 patients had non-union.8 patients had screw cut out.This report is for 16 patient's who had non-union.This report is for an unknown synthes proximal humeral internal locking system (philos) plate.This is report 3 of 5 for (b)(4).
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