MAUDE Adverse Event Report: 4WEB, INC. 4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE; INTERBODY FUSION DEVICE

Model Number	CSCR-3516-SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned as the screw remains implanted in patient.Review of production records did not indicate any issue related to manufacturing that may have contributed to the event.The cause of the event could not be established with the information available to the manufacturer.No revision surgery was scheduled as of the date of this report.
Event or Problem Description
It was reported to 4web medical that a 16mm cervical screw appears to have broken in patient.The issue was discovered during 3month post-op follow-up.The initial surgery was performed on (b)(6) 2024.

• Brand Name: 4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): 4WEB, INC.; 2801 network boulevard,; suite 620; frisco TX 75034
• Manufacturer (Section G): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• Manufacturer Contact: vareesha divakar ; 2801 network boulevard; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 20446326
• Report Number: 3009189869-2024-00018
• Device Sequence Number: 8090881
• Product Code: OVE
• UDI-Device Identifier: 00812998039326
• UDI-Public: (01)00812998039326(17)301001(10)R001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: CSCR-3516-SP
• Device Catalogue Number: CSCR-3516-SP
• Device Lot Number: R001
• 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: 09/17/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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
• Patient Sex: Female