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

Model Number	PSTS-MD0612-26-SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation nor radiographs provided.Review of production records did not indicate any issue related to manufacturing that may have contributed to the event.Pseudoarthrosis was reported and per information available, the patient had other comorbidities.The cause of the event could not be established with the information available to the manufacturer.
Event or Problem Description
It was reported to 4web medical that a revision surgery was performed to remove a 4web posterior cage that migrated.The revision surgery was performed about three and a half months post initial surgery.The 4web implant was removed and replaced with an expandable cage from a different vendor.No issues noted during the initial or revision surgery.The initial surgery was performed on (b)(6) 2024.

• Brand Name: 4WEB POSTERIOR 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: 20347906
• Report Number: 3009189869-2024-00017
• Device Sequence Number: 18103460
• Product Code: MAX
• UDI-Device Identifier: 00812998022984
• UDI-Public: (01)00812998022984(17)290601(10)D004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143258
• 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): 10/01/2024

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: PSTS-MD0612-26-SP
• Device Catalogue Number: PSTS-MD0612-26-SP
• Device Lot Number: D004
• 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: 09/03/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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: 57 YR
• Patient Sex: Male