MAUDE Adverse Event Report: 4WEB, INC. 4WEB LATERAL SPINE TRUSS SYSTEM; INTERVERTEBRAL FIXATION DEVICE

Model Number	LSCR-6560-NS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer that a revision surgery was performed on (b)(6) 2024 to replace lsts plate screw, lscr-6560-ns, with a shorter 4web screw, lscr-6550-ns.The issue was discovered during follow-up.The patient was also reported to be experiencing pain prior to revision surgery.The initial surgery was performed on (b)(6) 2024.
Additional Manufacturer Narrative
No product was returned to the manufacturer.The cause of revision could not be established with the information available to the manufacturer.No manufacturing deviations were noted during review of manufacturing records.If more information is made available, a supplemental report will be filed.

• Brand Name: 4WEB LATERAL SPINE TRUSS SYSTEM
• Common Device Name: INTERVERTEBRAL FIXATION 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: 20896816
• Report Number: 3009189869-2024-00020
• Device Sequence Number: 5005860
• Product Code: KWQ
• UDI-Device Identifier: 00812998048991
• UDI-Public: (01)00812998048991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203065
• 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): 12/10/2024

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: LSCR-6560-NS
• Device Catalogue Number: LSCR-6560-NS
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 79 YR
• Patient Sex: Male