This report is for an unknown pfna construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: 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).
|
This report is being filed after the review of the following journal article: zhang, c.Et al.(2018), optimizing stability in ao/ota 31-a2 intertrochanteric fracture fixation in older patients with osteoporosis, journal of international medical research, vol.46(5), pages 1768-1778 (china).The present study aimed to compare the functional and radiographic outcomes of it and pfna for managing primary ao/ota 31-a2 ihfs in a consecutive older osteoporotic cohort.From february 2013 to july 2015, a total of 326 patients (176 males and 150 females) with a mean age of 72.3 years were included in the study.164 patients were treated with pfna (synthes, solothurn, switzerland).The mean follow-up period of 43.5 months (range, 38¿48 months).The following complications were reported as follows: 91 patients died.1 patient had a superficial infection.75 patients had acceptable reduction results.22 patients had periprosthetic fractures and reoperations.(9 patients had a reoperation following cut-outs after pfna nails; 13 had periprosthetic fractures).2 patients had periprosthetic fractures revised to longer main nail.2 patients had periprosthetic fractures revised to plate.9 patients had periprosthetic fracture revised to arthroplasty.1 patient had cut-out revised to shorter screw/blade.8 patients had cut-out revised to arthroplasty.4 patients had cut-outs.2 patients had malunions.1 patient had nonunion.This is report 1 of 9 for (b)(4).This report is for a pfna construct.This complaint is linked to (b)(4).
|