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

Model Number	LSTS-PLT212-SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned to the manufacturer.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 migration could not be established.Information received did not indicate an issue with the device(s) involved.The cage remains implanted in the patient.The supplemental fixation was removed and replaced by a new 4web screws.
Event or Problem Description
It was reported to 4web that a revision surgery was required as 4web anterior spine truss system - stand alone cage was reported to have migrated anteriorly.Per information received, it is believed that the patient presented with pain about one and a half month post initial surgery.The initial surgery was completed using 2 4web screws and plate and was performed on (b)(6) 2024.Report one of three.

• Brand Name: 4WEB LUMBAR SPINE TRUSS SYSTEM
• 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 ; 8002857090
• MDR Report Key: 19493103
• Report Number: 3009189869-2024-00009
• Device Sequence Number: 20589232
• Product Code: OVD
• UDI-Device Identifier: 00812998049271
• UDI-Public: (01)00812998049271(17)300101(10)R002
• 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): 06/07/2024

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: LSTS-PLT212-SP
• Device Catalogue Number: LSTS-PLT212-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: 05/13/2024
• Initial Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: 42 YR
• Patient Sex: Male