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

Catalog Number	4633
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Skin Erosion (2075)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon reported exposure of implant requiring surgical intervention.

• Brand Name: SU-POR SURGICAL IMPLANTS
• Common Device Name: SU-POR SURGICAL IMPLANTS
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine rd; suite 206; newnan GA 30263
• Manufacturer (Section G): PORIFEROUS, LLC; 535 pine rd; suite 206; newnan GA 30263
• Manufacturer Contact: krista bradstreet ; 535 pine rd; suite 206; newnan, GA 30263 ; 7706833855
• MDR Report Key: 24261660
• Report Number: 3010781616-2026-00034
• Device Sequence Number: 18520062
• Product Code: KKY
• UDI-Device Identifier: 00815285024111
• UDI-Public: 00815285024111
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K140437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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 Catalogue Number: 4633
• Device Lot Number: 463325246113
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 09/02/2025
• 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: 10 YR
• Patient Sex: Male