MAUDE Adverse Event Report: PORIFEROUS, LLC SU-POR SURGICAL IMPLANT

Model Number	4633
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Expulsion (2933)
Health Effect - Clinical Codes	Necrosis (1971); Skin Erosion (2075)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a surgeon reported an explantation of an implant due to flap necrosis resulting in implant extrusion.The surgeon reported a noncompliant patient and stated the patient was not following postoperative instructions for protection.The implant was removed without any further complication.

• Brand Name: SU-POR SURGICAL IMPLANT
• Common Device Name: SU-POR SURGICAL IMPLANT
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine rd; ste 206; newnan GA 30263
• Manufacturer (Section G): PORIEROUS, LLC; 535 pine rd; ste 206; newnan GA 30263
• Manufacturer Contact: krista bradstreet ; 535 pine rd; ste 206; newnan, GA 30263 ; 7706833855
• MDR Report Key: 21552234
• Report Number: 3010781616-2025-00118
• Device Sequence Number: 8175672
• Product Code: KKY
• UDI-Device Identifier: 00815285024111
• UDI-Public: 00815285024111
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 03/07/2025

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
• Device Model Number: 4633
• Device Catalogue Number: 4633
• Device Lot Number: 463324256120
• 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: 09/29/2024
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2024
• 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 Sex: Unknown