510k: this report is for an unk - constructs: tomofix plate/screws/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.
|
This report is being filed after the review of the following journal article: takahara, t.Et al.(2021), mid-term results of medial open-wedge high tibial osteotomy based on radiological grading of osteoarthritis, archives of orthopaedic and trauma surgery, vol.Xx, pages 1-10 (japan).The purpose of this study is to evaluate the mid-term results of medial open-wedge high tibial osteotomy (owhto) based on kellgren¿lawrence (kl) grades.Between january 2010 and march 2014, 93 patients (109 consecutive knees) with medial compartment osteoarthritis (oa) underwent owhto using a tomofix plate (depuy-synthes, solothurn, switzerland) the mean age of the patients was 61.4 years, the 1mean follow-up was 64.2 months, the following complications were reported as follows: 3 patients had delayed bone union.22 patients had hinge fractures.26 patients had osteoarthritis progression.17 cases had undercorrection.7 cases had overcorrection.2 patients had additional surgeries.Unicompartment arthroplasty was done for 1 case because of necrosis of medial femoral condyle after owhto.Re-osteotomy was done for 1 case because of overcorrection and increasing tibial posterior slope.This report is for an unknown synthes tomofix.This report is for one (1) unk - constructs: tomofix plate/screws.This is report 1 of 1 for (b)(4).
|