MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: MATRIX ORBITAL PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for patients who were treated with matrix midface plate and screw system, matrix midface preformed orbital mesh, compact midface system between january 1, 2000 and september 30, 2020.The following complications were reported as follows: matrixmidface plate and screw system: 126 patients had subsequent surgery 3 months post index surgery.83 patients had infection 3 months post index surgery.37 patients had procedure- or device-related complication 3 months post index surgery.195 patients had subsequent surgery 12 months post index surgery.123 patients had infection 12 months post index surgery.56 patients had procedure- or device-related complication 12 months post index surgery.Matrixmidface preformed orbital mesh: 4 patients had subsequent surgery 3 months post index surgery.4 patients had infection 3 months post index surgery.2 patients had procedure- or device-related complication 3 months post index surgery.4 patients had subsequent surgery 12 months post index surgery.4 patients had infection 12 months post index surgery.2 patients had procedure- or device-related complication 12 months post index surgery.Compact midface system: 131 patients had subsequent surgery 3 months post index surgery.83 patients had infection 3 months post index surgery.37 patients had procedure- or device-related complication 3 months post index surgery.184 patients had subsequent surgery 12 months post index surgery.119 patients had infection 12 months post index surgery.61 patients had procedure- or device-related complication 12 months post index surgery.This is for the depuy matrixmidface plate and screw system, matrixmidface preformed orbital mesh, and compact midface system.A copy of the clinical evaluation form is being submitted with this regulatory report.This is report 5 of 6 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown constructs: matrix orbital plate/screws/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.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.

• Brand Name: UNK - CONSTRUCTS: MATRIX ORBITAL PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15058662
• MDR Text Key: 296210611
• Report Number: 2939274-2022-02716
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention