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

Model Number	4353
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced post operative exposure of the implant.Surgeon attributed the exposure to the dressing and performed intervention to salvage the implant and resolve the exposure.

• Brand Name: SU-POR PATIENT SPECIFIC SURGICAL IMPLANT
• Common Device Name: SU-POR PATIENT SPECIFIC SURGICAL IMPLANT
• 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: 19072430
• Report Number: 3010781616-2024-00109
• Device Sequence Number: 17837340
• Product Code: FWP
• UDI-Device Identifier: 00815285021899
• UDI-Public: 00815285021899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/09/2024

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: 4353
• Device Catalogue Number: 4353
• Device Lot Number: 435324030016
• 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: 03/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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