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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

No product was returned to the manufacturer.There is no information available on the initial surgery where the 4web cervical cage was implanted.A supplemental report will be submitted as further information becomes available.

Event Description

It was reported to the manufacturer that a revision surgery was performed on a 4web implant on (b)(6) 2021.The device involved in the adverse event is a stand-alone 4web cervical cage.No other information was provided to the manufacturer.The screws used in this cervical cage are being reported in this submission.Device 2 of 2.

• Brand Name: 4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE
• Type of Device: 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: 12990414
• MDR Text Key: 282211509
• Report Number: 3009189869-2021-00008
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male