This report is for an unknown dorsal plate (va-lcp forefoot/midfoot system)/unknown lot.Part and lot numbers 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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This report is being filed after the review of the following journal article: malagelada, f., welck, m.And clark, c.(2017), the dowel technique for first metatarso-phalangeal joint arthrodesis in revision surgery with bone loss, foot and ankle surgery, vol.24, issue 3, pages 224-228 (united kingdom).The aim of this article is to present a novel technique of longitudinal (proximo-distal) bone dowel arthrodesis for first mtpj arthrodesis with bone loss and review the clinical and radiological outcomes of our technique.Between august 2007 and february 2015, a total of 8 patients (7 females and 1 male) with a mean age of 60.5 years (range 45-80) underwent fixation using a dorsal plate (va-lcp forefoot/midfoot system, synthes, welwyn garden city, uk).The mean length og post-operative follow-up was 37.4 months (range 12-102).The following complications were reported as follows: a (b)(6) year-old female patient had unremitting pain at the latest follow-up (38 months post-operation).Despite the absence of clinical signs.They suspected atypical complex regional pain syndrome (crps) and she was treated symptomatically.Her index surgery was for non-union.A (b)(6) year-old female patient required removal of metalwork due to discomfort.Her index surgery was for silastic.A (b)(6) year-old male patient had a prominent plate.His index surgery was for a non-union after malunion revision.An unknown patient had a partial loss of sensation in the big toe which resolved.Her index surgery was for non-union.This is report 7 of 8 for (b)(4).This is for a dorsal plate (va-lcp forefoot/midfoot system).
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