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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Nerve Damage (1979)
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Event Date 07/17/2008 |
Event Type
Injury
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Manufacturer Narrative
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Exact date of event is unknown; july 17, 2008 is the date the literature article was published.This report is for an unknown synthes proximal humeral internal locking system (philos) plate/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: y.P.Acklin, r.Jenni, m.Walliser, and c.Sommer (2009).Minimal invasive philos®-plate osteosynthesis in proximal humeral fractures.European journal of trauma and emergency surgery no.1 page 35-39.(switzerland).The objective of this study was to evaluate the results and complexity of surgery of proximal humeral fractures with a minimal invasive (mipo) approach.Between january 2003 and june 2006, a total of 29 patients (20 females, 9 males) with proximal humerus fracture were evaluated prospectively.The mean age was 64 years ranging from 16 to 91.Fractures meeting the indications for osteosynthesis according to neer (> 45° angulation, > 1 cm cranial displacement of one or both tuberosities) were operated with a proximal humerus plate (philos®, synthes®, switzerland).All locally resident patients were followed up clinically (constant¿murley score) and radiologically.The mean follow-up time was 12 months (6¿32).The complications were reported as follows: 1 anterior part of the axillary nerve was injured.This report is for an unknown synthes proximal humeral internal locking system (philos) plate.This is report 4 of 4 for (b)(4).
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Search Alerts/Recalls
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