MAUDE Adverse Event Report: PORIFEROUS, LLC. SU-POR PATIENT-SPECIFIC IMPLANTS; SU-POR PATIENT SPECFIC

Model Number	4353
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On december 8, 2025, the surgeon notified poriferous regarding a patient case involving an implant infection that requires a revision surgery.Additional information was requested but not provided.

• Brand Name: SU-POR PATIENT-SPECIFIC IMPLANTS
• Common Device Name: SU-POR PATIENT SPECFIC
• 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: 23956954
• Report Number: 3010781616-2025-00132
• Device Sequence Number: 17549308
• Product Code: KKY
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: 4353
• Device Catalogue Number: 4353
• Device Lot Number: 435323202110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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: 8 YR
• Patient Sex: Male