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

Model Number 4006

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

A patient required secondary surgery due to swelling (adema).

• Brand Name: SU-POR SURGICAL IMPLANTS
• Type of Device: CRAN IOMAXILLOFACIAL IMPLANT
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine road; suite 206; newnan GA 30263
• Manufacturer (Section G): PORIRFEROUS, LLC; 535 pine road; suite 206; newnan GA 30263
• Manufacturer Contact: krista bradstreet ; 535 pine road; suite 206; newnan, GA 30263 ; 7706833855
• MDR Report Key: 12033989
• MDR Text Key: 257219960
• Report Number: 3010781616-2021-00082
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00815285020069
• UDI-Public: 00815285020069
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K140437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4006
• Device Catalogue Number: 4006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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