MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT; FACIAL IMPLANT

Model Number 89021

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/21/2022

Event Type  Injury  

Event Description

According to the initial report, a microtia patient had surgery on (b)(6) 2022 and now has a fungal infection of his implant.The patient will undergo surgical revision.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, a microtia patient had surgery on (b)(6) 2022 and now has a fungal infection of his implant.The patient will undergo surgical revision.

Manufacturer Narrative

Multiple attempts for additional information were made to no avail.The product was not returned for further evaluation.The lot number was traced, and a review of the manufacturing records was performed.There were no deviations or non-conformances identified during the processing of the implant.A review of the sterility results was conducted.All sterility specifications met requirements upon product release.Based on the information provided, a definitive root cause could not be established.A review of the risk analysis was performed.Non-sterile products are listed as a serious hazard.The sterility cycle parameters much be met as well as the volume of pyrogens on the device.In this case, all sterility parameters were met and the pyrogen results were well within range.Conclusively, infection is a known inherent risk of any surgical procedure.The instructions for use list superficial and/or deep infection as a possible effect.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Type of Device: FACIAL IMPLANT
• Manufacturer (Section D): MATRIX SURGICAL USA; 98 bledsoe rd.; newnan GA 30265
• Manufacturer (Section G): MATRIX SURGICAL USA; 98 bledsoe rd.; newnan 30265
• Manufacturer Contact: darren troutman ; 98 bledsoe rd.; newnan, GA 30265 ; 4048554592
• MDR Report Key: 16278757
• MDR Text Key: 308585883
• Report Number: 3009383407-2022-00002
• Device Sequence Number: 1
• Product Code: FZD
• UDI-Device Identifier: 00855421005413
• UDI-Public: 00855421005413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 89021
• Device Lot Number: 007020922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male