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

Model Number OP7542

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/27/2021

Event Type  Injury  

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 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
• Type of Device: FACIAL IMPLANT, MANDIBLE
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd., sw ste#; atlanta GA 30349
• Manufacturer Contact: mr. troutman ; 4025 welcome all rd., sw; ste# 120; atlanta, GA 30349 ; 4043440283
• MDR Report Key: 12379608
• MDR Text Key: 268554524
• Report Number: 3009383407-2021-00001
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00855421005659
• UDI-Public: 00855421005659
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OP7542
• Device Lot Number: 001010221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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