MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: MATRIX ORBITAL; PLATE, BONE

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

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown screws: matrix orbital/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: scolozzi p, bachelet j-t, courvoisier ds (2020), are inferior rectus muscle displacement and the fracture¿s size associated with surgical repair decisions and clinical outcomes in patients with pure blowout orbital fracture?, j oral maxillofac surg, volume 78, pages e1-2280 to e10-2280, (switzerland).The purpose of this study was to evaluate the association between inferior rectus muscle (irm) displacement and fracture size and the surgical repair decisions and clinical outcomes in patients with blowout fractures (bofs).Between 2012 and 2018, 108 patients with pure blowout orbital fracture with at least 1-year period of medical and ophthalmologic follow-up were included in the study.There were 79 men and 29 women with a mean age of 46.8 +/-23 years.34 patients underwent surgical repair while 74 patients underwent conservative treatment.Surgical repair was performed via a transconjunctival approach and the defect was reconstructed using preformed titanium orbital meshes, the unknown synthes matrix midface titanium orbital mesh plate.All patients underwent an immediate (within 6 hours) ophthalmologic assessment on the day of trauma.A comprehensive orthoptic assessment was performed within 48 hours of the injury and at follow-up intervals of 10 days and 1, 3, 6, and 12 months.Complications were reported as follows: 3 patients had annoying diplopia at 1 years postoperatively.3 patients had more than 2mm enopthalmos at 1 year postoperatively.This report is for the unknown synthes matrix midface titanium orbital mesh plate and screws.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.

• Brand Name: UNK - SCREWS: MATRIX ORBITAL
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12290706
• MDR Text Key: 265576175
• Report Number: 8030965-2021-06504
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Patient Sequence Number: 1