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

Model Number	24-2566
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Microtia repair following traumatic loss of ear in a car accident.Initial implantation: (b)(6) 2024, no complications at the time of surgery.(b)(6) 2024 patient was seen in clinic no sign of infection or complication.Patient was not following post operative care instructions provided by operating surgeons.(b)(6) 2024 the patient presented with exposure.No medical or surgical intervention taken place yet but is planned.We will update with additional information as collected.

• 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): PORIFEROUS, 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: 20712282
• Report Number: 3010781616-2024-00114
• Device Sequence Number: 9903681
• Product Code: FWP
• UDI-Device Identifier: 00815285021899
• UDI-Public: 00815285021899
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/18/2024

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: 24-2566
• Device Catalogue Number: 4353
• Device Lot Number: 435324165084
• 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: 10/18/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American