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

Model Number	PSTS-SM0609-22-SP
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
About two months after the original surgery, the patient indicated pain and numbness.During a follow-up appointment, the surgeon observed that the posterior implant had migrated posteriorly.As a result, the surgeon performed a revision surgery to explant the cage.
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.The cause of the event could not be established with the information available to the manufacturer.

• 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: upasana veturi ; 2801 network boulevard; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 15340993
• Report Number: 3009189869-2022-00006
• Device Sequence Number: 20119648
• Product Code: MAX
• UDI-Device Identifier: 00812998022298
• UDI-Public: (01)00812998022298(17)281001(10)D006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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-SM0609-22-SP
• Device Catalogue Number: PSTS-SM0609-22-SP
• Device Lot Number: D006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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 Age: 59 YR
• Patient Sex: Male