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

Model Number	OP7542
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the initial report, a patient is undergoing a surgery revision due to an infection of a right madibular implant.The device was implanted on (b)(6) 2021 and the infection was reported on july 27th.Requests for additional information were made to no avail.The product was not returned for evaluation.The lot number was traced and a review of the manufacturing records were performed.There were no non-conformances identified and no deviations were documented throughout the processing of the device.A review of the sterility process and results was conducted.All sterility processing specifications were met and the lal results were well below the limit.As no additional information was received, the investigation remains inconclusive.A definitive root cause could not be determined.Conclusively, infarction is a known inherent risk of any surgical procedure.The instructions for use list superficial and/or deep infection as a possible adverse effect.
Event or Problem Description
According to the initial report, a patient is undergoing a surgery revision due to an infection of a right mandibular implant.The device was implanted on (b)(6) 2021 and the infection was reported on june 27th 2021.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Common Device Name: FACIAL IMPLANT, MANDIBLE
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd., sw ste#; atlanta GA 30349
• MDR Report Key: 12379608
• Report Number: 3009383407-2021-00001
• Device Sequence Number: 4407143
• Product Code: KKY
• UDI-Device Identifier: 00855421005659
• UDI-Public: 00855421005659
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: OP7542
• Device Lot Number: 001010221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention