MAUDE Adverse Event Report: 4WEB, INC. 4WEB CERVICAL SPINE TRUSS SYSTEM - STANDALONE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	CSCR-3514-SD-SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to 4web medical that a 4web cage, plate and a pair of screws were explanted due to adjacent level disease.The revision was performed about five months post initial surgery, on (b)(6)2024.No issues or complications reported during the revision surgery.Two set of screws were used during the surgery.It is unknown which pair is related to the reported incident.Therefore, both devices are being reported.(device 4 of 4).
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.The cause of the event could not be established with the information available to the manufacturer.

• Brand Name: 4WEB CERVICAL SPINE TRUSS SYSTEM - STANDALONE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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: 21225019
• Report Number: 3009189869-2025-00004
• Device Sequence Number: 8443234
• Product Code: OVE
• UDI-Device Identifier: 00812998039371
• UDI-Public: (01)00812998039371(17)310301(10)R005
• 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
• Device Explanted 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): 01/23/2025

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-3514-SD-SP
• Device Catalogue Number: CSCR-3514-SD-SP
• Device Lot Number: R005
• 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: 12/26/2024
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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 Age: 49 YR
• Patient Sex: Female