Device used for treatment, not diagnosis patient id, age, dob and weight not provided for reporting.Additional product code: hrs, hwc.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: part# 02.124.419, lot# 9195289.Manufacturing location: (b)(4).Manufacturing date: 07.Oct.2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that a patient underwent a removal of a variable angle (va) condylar plate on (b)(6) 2017 due to nonunion and a broken plate.The original surgery was conducted about six (6) weeks ago and the construct included a va condylar plate, an unknown cable to help with the periprosthetic femur fracture repair, two (2) 4.5 mm cortical screws, five (5) va cannulated locking screws and four (4) va locking screws.All parts but the plate were removed intact.The removal surgery was successful and uneventful.The patient was reported to be stable.It is unknown if the patient will be revised to another set of implants.Concomitant devices reported: cable (quantity# 1).The 4.5 mm cortical screws (quantity# 2).Va cannulated locking screws (quantity# 5).Va locking screws (quantity# 4).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
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