Device was used for treatment not diagnosis.This report is for an unknown tomofix system.(b)(4).Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
|
This report is being filed after the subsequent review of the following journal article: dexel, j., fritzsche, h., beyer, f., harman, m., lutzner, j.(2015) open-wedge high tibial osteotomy: incidence of lateral cortex fractures and influence of fixation device on osteotomy healing.Knee surg sports traumatol arthrosc.The purpose of this study was to evaluate osteotomy healing after fixation with two different locking plates.Between 2003 and 2012, a total of 69 medial open-wedge high tibial osteotomy (hto) were performed on patient with medial compartment knee osteoarthritis and varus malalignment.After achieving the preoperatively designated leg axis correction, the osteotomy was fixed with an internal plate fixator with locking screws, either the tomofix (synthes, oberdorf, switzerland) implant from april 2003 until september 2009 or the position hto maxi plate of a competitor from july 2009 until december 2012.Screw loosening occurred in 2 patients.This report is for an unknown tomofix system.This is report 2 of 2 for (b)(4).
|