This report is for an unknown screws: matrixneuro/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: harris, m.A., vidor, i.A., and sivak-calcott, j.(2011), amniotic membrane in medial canthal reconstruction, opthalmic plastic and reconstructive surgery, vol.27(2), pages 135-136 (usa).The purpose of this study is to describe the use of amniotic membrane for reconstruction of large medial canthal defects.Between 2003 to 2009, a total of four patients who were diagnosed with basal cell carcinoma, basal cell carcinoma with squamous differentiation, moderately differentiated squamous cell carcinoma, and poorly differentiated squamous cell carcinoma were treated with a y-shaped titanium plate (synthes matrixneuro system, synthes inc., west chester, pa, u.S.A.).All patients had reepithelialization 6 weeks after surgery.Follow-up ranged between 1 month and 5 years.The article did not specify which of the devices were being used to capture the following complications: 1 case had late visual decline due to age-related macular degeneration.1 case had limited extraocular movement preoperatively (superior).2 cases had mild restricted movement in all directions, and 2 patients were unchanged from preoperative measurements.2 patients reported diplopia only in peripheral gaze, postoperatively.1 patient had preoperative tear film deficiency with keratopathy, requiring ocular lubrication.This was unchanged postoperatively.1 patient reported preoperative tearing; 3 patients reported frequent tearing postoperatively.This report is for a y-shaped titanium plate (synthes matrixneuro system, synthes inc., west chester, pa, u.S.A.).This report is for one (1) unk - screws: matrixneuro.This is report 2 of 2 for (b)(4).
|