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

Model Number	89020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient got an infection following implantation.
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
Patient got an infection following implantation.
Additional Manufacturer Narrative
Multiple attempts for additional information were made to no avail.Manufacturing records were not reviewed as the lot number was not provided.A definitive root cause could not be established as pertinent information was unable to be obtained.Additionally, infection is a known risk inherent risk of any surgical procedure.The instructions for use list superficial and/or deep infection as a possible adverse event.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Common Device Name: CRANIAL IMPLANT
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd. ste #120; atlanta GA 30349
• Manufacturer Contact: darren troutman ; 4025 welcome all rd. ste# 120; atlanta, GA 30349 ; 4048554592
• MDR Report Key: 14597475
• Report Number: 3009383407-2022-00001
• Device Sequence Number: 2098349
• Product Code: MVA
• UDI-Device Identifier: 00855421005406
• UDI-Public: 00855421005406
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 89020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown