This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date (b)(6) 2012 and (b)(6) 2014.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.(b)(4).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: min ryu, s.Et al (2008), staged treatment of bicondylar tibial plateau fracture (schatzker type v or vi) using temporary external fixator: correlation between clinical and radiological outcomes, knee surgery & related research 2018 vol.30(3) 261-268 (south korea) doi.Org/10.5792/ksrr.17.008 this study aims to investigate clinical and radiological results of staged treatment using a temporary external fixator in bicondylar tibial plateau fractures (tpfs) and to evaluate correlation between prognostic factors and postoperative clinical outcomes.Between january 2012 and january 2014, 70 patients underwent operations for bicondylar tibial plateau fractures (tpfs).Of these patients, 24 (13 male and 11 female) with schatzker type v or vi fracture were selected and retrospectively investigated in this study.In the secondary plate fixation for dual plating (tubular plate or proximal medial plate [synthes, oberdorf, switzerland], proximal lateral locking plate [zimmer, warsaw, in, usa]) was used.The mean follow-up was 24.2 months (range, 15 to 32 months).The following complications were reported: a (b)(6) year-old male required revision surgery due to metal failure a (b)(6) year-old male had total knee arthroplasty due to postoperative arthritis 2 years after first fixation.1 patient had device breakage due to early ambulation (this patient was excluded from the study/exclusion criteria).This report is for an unknown synthes plate.This is report 2 of 6 for (b)(4).
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