This report is for an unk - constructs: plate/screws (for ao periarticular plate) /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: pai v., coulter g., pai v., (2007) minimally invasive plate fixation of the tibia ,international orthopaedics volume 31, pages 491¿496 (new zealand).This study aims to report the functional clinical and radiographic results of 26 distal tibial fractures that have been plated with minimally invasive techniques performed or supervised by the senior surgeon (vp) and independently assessed by an observer (gc).Between january 2000 and december 2003, a consecutive series of 26 fractures of the distal tibia were treated with a minimally invasive fixation.A total of 23 patients were eligible for the study (15 males, 8 females) with mean age at the time of injury was 43 years (range: 17-72).Surgery was performed using the zimmer medial distal periarticular plate (precontoured) in 18 cases, with the ao (synthes) periarticular plate in two and the standard ao dcp contoured by hand in six (the intact contralateral tibia was used as a template for contouring the ao plates).The minimal follow-up was 12 months, with a range from 14¿42 months.Complications reported as follows: at 12 months, two patients had fair and one had a poor result.Three had moderate pain.Radiological assessment revealed satisfactory alignment in all but one.One case of superficial infection treated, as an outpatient, with oral antibiotics and one had superficial saphenous nerve irritation.There was one failure requiring refixation, the initial fixation with an ao periarticular plate resulted in an external rotation deformity of more than 30°.Fig.4 a osteoporotic a3 fracture.B healing in good alignment with some backing out of screws.This report is for one (1) unk - constructs: plate/screws (for ao periarticular plate).This report captures reported adverse events of moderate pain, radiological assessment revealed satisfactory alignment in all but one, nerve irritation.This is report 2 of 6 for complaint (b)(4).
|