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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrix orbital plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: schlittler, f.Et al.(2020), what are the limitations of the non-patient-specific implant titanium reconstruction of the orbit?, british journal of oral and maxillofacial surgery, vol.58, pages e80-e85 (united kingdom).The purpose of this study was to estimate the frequency of implant malposition and revision procedures after primary orbital repair with preformed plates and to identify cases where the primary use of a customised plate would help to prevent revision surgery.Between august 2017 and july 2018, a total of 79 patients with pure orbital trauma were treated with a titanium orbital plate (matrixorbitaltm, depuy synthes).There were 68 males and 11 females.The following complications were reported as follows: 12 patients was poor for implant position.5 patients had revision surgery.The major reason for revision was that the defect was too large for the prescribed plate.This report is for an unknown synthes matrixorbital.This is report 1 of 1 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 for one (1) unk - constructs: matrix orbital plate/screws.

• Brand Name: UNK - CONSTRUCTS: MATRIX ORBITAL PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12350996
• MDR Text Key: 267662028
• Report Number: 8030965-2021-07028
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening