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

Model Number	4353
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An implant was explanted due to fracture.Another implant was placed within the same surgery with no complications reported.

• 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 rd; suite 206; newnan GA 30263
• Manufacturer Contact: krista bradstreet ; 535 pine rd; suite 206; newnan, GA 30263 ; 7706833855
• MDR Report Key: 20346551
• Report Number: 3010781616-2024-00111
• Device Sequence Number: 8023983
• Product Code: FWP
• 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
• Device Implanted Year: 2020
• Device Explanted 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): 10/01/2024

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 Expiration Date: 06/12/2024
• Device Model Number: 4353
• Device Catalogue Number: 4353
• Device Lot Number: 435319164063
• 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: 09/02/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2019
• 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