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

Model Number	22-1684
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported to physician's office with an exposure of the implant without presence of infection.Physician began treating patient with dressing changes twice daily.Explantation was performed on (b)(6) 2023 and a new implant was placed.No further complications were reported.

• Brand Name: SU-POR PATIENT SPECIFIC SURGICAL IMPLANT
• 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: 16364195
• Report Number: 3010781616-2023-00097
• Device Sequence Number: 17845859
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: 22-1684
• Device Catalogue Number: 4353
• Device Lot Number: 435322109053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 20 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White