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

Model Number	CSTS2-MD0708-SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned.Production records of all the devices involved in the initial procedure were reviewed, no issues related to manufacturing were noted that may have contributed to the event.There is no evidence that the 4web devices contributed to the revision surgery.
Event or Problem Description
It was reported to 4web medical that a 4web cervical cage, plate, and screws were explanted following a fall that compromised the construct.The revision surgery was performed on (b)(6) 2026, less than one month after the initial surgery.No issues or complications were reported during the revision procedure.Device 1 of 3.

• 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: 24438626
• Report Number: 3009189869-2026-00002
• Device Sequence Number: 10211872
• Product Code: ODP
• UDI-Device Identifier: 00810074758383
• UDI-Public: (01)00810074758383(17)320701(10)D010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 02/24/2026

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: CSTS2-MD0708-SP
• Device Catalogue Number: CSTS2-MD0708-SP
• Device Lot Number: D010
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/24/2026
• 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: Unknown