MAUDE Adverse Event Report: PORIFEROUS, LLC SU-POR SURGICAL IMPLANTS; PROSTHESIS, CHIN, INTERNAL

Model Number	22-1806 REV B
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Pocket Erosion (2013); Post Operative Wound Infection (2446)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented with purulent drainage coming out of the exposure upon palpation of the surrounding area.

• Brand Name: SU-POR SURGICAL IMPLANTS
• Common Device Name: PROSTHESIS, CHIN, INTERNAL
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine road; suite 206; newnan GA 30263
• Manufacturer (Section G): PORIFEROUS, 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: 16436983
• Report Number: 3010781616-2023-00098
• Device Sequence Number: 16931568
• Product Code: FWP
• UDI-Device Identifier: 00815285021899
• UDI-Public: 00815285021899
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 22-1806 REV B
• Device Catalogue Number: 4353
• Device Lot Number: 435322292132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 22 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White