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

Model Number CSTS-MD0708

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Two (2) non-sterile cervical spine implants were returned to the manufacturer in a biohazard package.Upon investigation, it appeared that these were explanted from a patient and the implants were identified by the serial number on the devices.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.The surgeon was contacted by the manufacturer, however, no information could be gathered that may be relevant to the investigation of the devices.

Event Description

Two (2) non-sterile cervical spine implants were returned to the manufacturer.Upon inspection, it was identified that the devices were explanted.No information was available on the explantation.It is possible that a revision surgery may have been performed, however, no confirmation was received.(device 2 of 2).

• Brand Name: 4WEB CERVICAL SPINE TRUSS SYSTEM
• 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 ; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 16772855
• MDR Text Key: 313612595
• Report Number: 3009189869-2023-00004
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 00812998020126
• UDI-Public: (01)00812998020126(11)180625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSTS-MD0708
• Device Catalogue Number: CSTS-MD0708
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2018
• 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): Other
• Patient Age: 66 YR
• Patient Sex: Female