MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT; HDPE FACIAL IMPLANT - TWO-PIECE CHIN - LARGE

Model Number	OP8322
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During this investigation no further product or patient information have been reported.The device will not be available for testing; therefore, no product deficiency can be evaluated.There is the possibility that clinical factors may have contributed to this event.At this time the cause of the infection is unknown.Based on the lack of information received, the cause of the reported incident could not be determined.No information or device were received for evaluation.
Event or Problem Description
Phone call message was received by (b)(6) (vp marketing) on (b)(6) 2019 from surgeon reporting that a patient had developed a post-operative infection after the implantation of the two-piece chin.No other information was received at the time of this initial contact.Product information was made available by the review of distribution records.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Common Device Name: HDPE FACIAL IMPLANT - TWO-PIECE CHIN - LARGE
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all road; suite 120; atlanta GA 30349 1879
• MDR Report Key: 8362264
• Report Number: 3009383407-2019-00004
• Device Sequence Number: 2306738
• Product Code: KKY
• UDI-Device Identifier: 00855421005499
• UDI-Public: 00855421005499
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/22/2019

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 Expiration Date: 06/01/2022
• Device Model Number: OP8322
• Device Catalogue Number: OP8322
• Device Lot Number: 015050617
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: Required Intervention