MAUDE Adverse Event Report: PORIFEROUS, LLC SU-POR SURGICAL IMPLANTS; No Match

Model Number	4028
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During initial implantation, a 14mm sphere was placed and operating surgeon described difficulty suturing patients muscles and coving the implant with adequate soft tissue.The surgeon attempted intervention three times to increase soft tissue coverage and promote healing, but was unable to adequately cover the device.The patient had previously undergone radiation therapy on the soft tissues and surgeon described failure due to failure of the soft tissues.On july 25th the 14mm sphere was explanted and a 16mm quadro-port sphere was placed.The surgeon was able to suture the muscles to the replacement device and no further complications have been reported.

• Brand Name: SU-POR SURGICAL IMPLANTS
• Common Device Name: No Match
• 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: 17825253
• Report Number: 3010781616-2023-00105
• Device Sequence Number: 6138298
• Product Code: KKY
• UDI-Device Identifier: 00815285022698
• UDI-Public: 00815285022698
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/25/2023

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: 05/01/2024
• Device Model Number: 4028
• Device Catalogue Number: 4028
• Device Lot Number: 402819144054
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5 MO
• Patient Sex: Male