MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT; EAR BASE EXTENDED-RIGHT/ HELICAL RIM

Model Number	8330/8328
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
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 (b)(6) patient with an infection that needs his implant replaced.There was an exposure that led to implant contamination.Not a real infection.
Event or Problem Description
According to the initial report, a korean patient with an infection that needs his implant replaced.There was an exposure that led to implant contamination.Not a real infection.
Additional Manufacturer Narrative
It was reported to matrix surgical usa that a patient had an implant exposure that led to contamination.The surgeon indicated that the issue was not a real infection.The event occurred years after surgery and may have been attributed to an injury sustained during a haircut.The infection was reported to be a presumption of contamination secondary to the implant exposure.Additional information was requested including the current status of the patient, the lot number, and the date in which the event occurred.The surgeon indicated that there was no issue with the implant and no further additional information was received.A definitive lot number was not provided; therefore, a device history review was not performed.Conclusively, infection is a known inherit risk of any surgical procedure.The instructions for use list superficial and/or deep infection as a possible adverse effect.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Common Device Name: EAR BASE EXTENDED-RIGHT/ HELICAL RIM
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd. ste# 120; atlanta GA 30349
• MDR Report Key: 9401291
• Report Number: 3009383407-2019-00006
• Device Sequence Number: 11394276
• Product Code: KKY
• UDI-Device Identifier: 00855421005284
• UDI-Public: 00855421005284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 8330/8328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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