MAUDE Adverse Event Report: PORIFEROUS, LLC SU-POR SURGICAL IMPLANTS; CRAN IOMAXILLOFACIAL IMPLANT

Model Number	4006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient required secondary surgery due to swelling (adema).

• Brand Name: SU-POR SURGICAL IMPLANTS
• Common Device Name: CRAN IOMAXILLOFACIAL IMPLANT
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine road; suite 206; newnan GA 30263
• MDR Report Key: 12033989
• Report Number: 3010781616-2021-00082
• Device Sequence Number: 11803848
• Product Code: KKY
• UDI-Device Identifier: 00815285020069
• UDI-Public: 00815285020069
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K140437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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 Model Number: 4006
• Device Catalogue Number: 4006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/21/2021
• 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