There are multiple patients all information is provided in the article.Implant date is between may 2014 and may 2016.This report is for an unknown 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.
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This report is being filed after the review of the following journal article: bhardwaj, a., sharma, g., patil, a., and rahate, v.(2018), comparison of plate osteosynthesis versus non-operative management for mid-shaft clavicle fractures¿a prospective study, injury, vol.49, issue 6, pages, 1104-1107 (india).The aim of the study was to compare clinical and functional outcome between plate osteosynthesis and conservative line of management in middle-third clavicle fractures.Between may 2014 and may 2016, a total of 36 patients (8 males and 28 females) with closed clavicle fractures were treated with an lcp superior clavicle plate (depuy synthes, switzerland).The following complications were reported as follows: 1 patient had a malunion.1 patient had superficial infection which responded well to oral antibiotics.2 patients had plate prominence.1 patient had a fall 3 months after the surgery and had an implant breakage.This report is for an unknown synthes lcp superior clavicle plate.This report is for one (1) unknown plate.This is report 2 of 4 for (b)(4).
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