MAUDE Adverse Event Report: SYNTHES GMBH UNK - RESORBABLE IMPLANTS: MESH; SURGICAL MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - resorbable implants: mesh/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.

Event Description

This report is being filed after the review of the following journal article: chai, g.Et al (2021), theoretical model of pediatric orbital trapdoor fractures and provisional personalized 3d printing-assisted surgical solution, bioactive materials, vol.6 (xx), pages 559¿567 (china).The aim of this study is to conduct numerical simulation to analyze stress during external force-induced orbital blowout fractures and explore the probabilities attached to various fracture scenarios.Children treated for orbital trapdoor fractures were then studied in retrospect to verify the author's theoretical construct.Between 2014 to 2019, a total of 36 patients (22 male and 14 female) with ages ranging from 3 to 15 years, were included in the study.All patients underwent surgical repairs of orbital trapdoor fractures.Surgery was performed using absorbable mesh plates (plla/pga 85:15, rapidsorb orbfloor plate 1.5 or 0.5 mm; depuy synthes, raynham, ma, usa).Patients were monitored during return visits at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery.The mean follow-up period was unknown.The following complications were reported as follows: out of the 36 patients, ocular motility restriction was noted in 10 patients at 1-week follow-up, 7 patients at 1-month, 3 at 3-month, and 2 at 6-month.Diplopia was noted in 15 patients at 1-week, 12 patients at 1-month follow-up, 5 patients at 3-month, 3 patients at 6-month, and 2 patients at 12-month follow-up enophthalmos (> 2 mm) was seen in 1 patient at 3-month, 3 patients at 6-month, and 6 patients at 12 months follow-up.This report is for an unknown synthes resorbable mesh.This report is for one (1) unk - resorbable implants: mesh.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - RESORBABLE IMPLANTS: MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11957479
• MDR Text Key: 267272823
• Report Number: 8030965-2021-04652
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1