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

Model Number	89021
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3009383407-2022-00002
• Device Sequence Number: 7058139
• Product Code: FZD
• UDI-Device Identifier: 00855421005413
• UDI-Public: 00855421005413
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 89021
• Device Lot Number: 007020922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male