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

Model Number	CSCR-3516-SD-SP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product remains implanted.No radiographs were provided.Production records were reviewed for the device involved, no issues related to manufacturing were noted that may have contributed to the event.It was reported that the patient has congenital abonormalities and very hard bone in some places.The exact cause of the incident could not be established.
Event or Problem Description
It was reported to the manufacturer that a 4web cervical screw fractured during surgery.Information received indicated that significant amount of force was applied while attempting to fully seat the screw in order to engage the anti-backout plate, at which point the screw head fractured.The threaded portion of the screw remains implanted in the patient's bone.The second screw was subsequently implanted without issue, and the anti-backout plate was engaged.No additional complications or patient injury were reported.The surgery was completed successfully.

• Brand Name: 4WEB CERVICAL SPINE TRUSS SYSTEM
• 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: 25291346
• Report Number: 3009189869-2026-00007
• Device Sequence Number: 9677210
• Product Code: OVE
• UDI-Device Identifier: 00812998038961
• UDI-Public: (01)00812998038961(17)320701(10)R010
• 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: 2026
• 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): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CSCR-3516-SD-SP
• Device Catalogue Number: CSCR-3516-SD-SP
• Device Lot Number: R010
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: 66 YR
• Patient Sex: Male