This report is for an unk - nail head elem: tfn lag screw /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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
|
Device report from synthes reports an event in (b)(6), south as follows: this report is being filed after the review of the following journal article: hwang, j.Et al.(2020), varus displacement of intertrochanteric femur fractures on injury radiographs is associated with screw cutout, european journal of orthopedic surgery & traumatology, vol.Xx, pages 1-5 (south korea).The purpose of this study was to determine if varus displacement of intertrochanteric femur fractures on injury radiographs is associated with screw cutout after fixation.A total of 366 patients (252 females and 114 males) with a median (interquartile) age of 75 (63¿83) were treated with a short cephalomedullary nails (cmn) or long sliding hip screws (shs).Implants used were dynamic hip screw (synthes, raynham ma) for 21 patients, trochanteric fixation nail (synthes, raynham ma) for 123 patients and trochanteric fixation nails advanced (synthes, raynham ma) for 6 patients.Other brands used were stryker, zimmer and smith and nephew.The median follow-up was 12 (6¿27) months.The following complications were reported as follows: 142 patients presented with varus displacement.9 patients had screw cutouts.(2 from stryker; 5 from zimmer).Eight of the nine cutouts occurred in patients with varus displacement.Seven had poor/adequate reductions.2 patients who were treated with a synthes trochanteric fixation nail had screw cutouts.This report is for an unknown synthes dhs, tfn, and tfna.This report is for (1) unk - nail head elem: tfn lag screw.This is report 4 of 5 (b)(4).
|