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

Model Number	ASCR-5023-T25-SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned to the manufacturer.No radiographs were provided.The production records were reviewed for the product involved.No manufacturing deficiences were identified that could have contributed to this event.The exact cause of non-union could not be established.
Event or Problem Description
It was reported to 4web that a revision surgery was required due to non-union of (b)(4) anterior spine truss system - stand alone cages.The report was submitted about nine months post initial sugery.The initial surgery was performed on (b)(6) 2023.The (b)(4) screws used during surgery are being reported in this submission.Report two of three.

• Brand Name: 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE
• Common Device Name: INTERVERTEBRAL 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
• MDR Report Key: 18522422
• Report Number: 3009189869-2024-00002
• Device Sequence Number: 19749070
• Product Code: OVE
• UDI-Device Identifier: 00810074753401
• UDI-Public: (01)00810074753401(17)281201(10)R002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: ASCR-5023-T25-SP
• Device Catalogue Number: ASCR-5023-T25-SP
• Device Lot Number: R002
• 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: Not provided
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 Sex: Female