If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown synthes proximal humeral internal locking system (philos) locking 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.(b)(4).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: carbone, s.Et al (2018), humeral head inferior subluxation in proximal humerus fractures, international orthopaedics, vol.42(4), pages 901-907 (italy).The objectives of this retrospective observational study are: to propose a simple and reliable radiologic method for detecting static inferior subluxation of the humeral head and to calculate the relative intra- and inter-observer reliability; to evaluate the presence of static inferior subluxation pre- and post-surgery; and to determine if it may present a precocious sign of screw joint perforation.Between june 2012 and december 2015, a total of 150 patients were included in the study.These patients were divided into two groups: semi-rigid fixation (humerusblock, synthes, oberdorf, switzerland) (group i) consisted of 105 patients (31 male and 71 female) with a mean age of 68 years (range, 49-87 years) and rigid fixation (proximal humeral internal locking system (philos) locking plate, synthes, oberdorf, switzerland) (group ii) consisted of 45 patients (22 male and 23 female) with a mean age of 65 years (range, 32-69 years).Clinical evaluation was recorded at 12 months of follow-up using constant score by a researcher not involved in surgery and follow-ups.The following complications were reported as follow under semi-rigid fixation (humerusblock, synthes, oberdorf, switzerland) (group i): 13 cases had inferior subluxation at 3 months follow-up.4 cases showed persistent inferior subluxation at 12 months follow-up.4 cases had pin or screw articular perforation in group 1 confirmed with ct scans these four patients had complete hardware removal at 3 months.The following complications were reported as follow under semi-rigid fixation rigid fixation (proximal humeral internal locking system (philos) locking plate, synthes, oberdorf, switzerland) (group ii): 9 cases had inferior subluxation at 3 months follow-up.3 cases showed persistent inferior subluxation at 12 months follow-up.2 cases had pin or screw articular perforation in group 2 confirmed with ct scans these two patients had removal of the penetrating screws at 3 months.3 cases had pin or screw articular perforation in group 2 confirmed with ct scans at 12 months.This report is for the patients who continued to experience subluxation postoperatively.This report is for an unknown synthes proximal humeral internal locking system (philos) locking plate.This is report 1 of 5 for (b)(4).
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