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

Model Number	CSTS-MD0707
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem 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 1 of 2).
Additional 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 device.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.

• Brand Name: 4WEB CERVICAL 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 ; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 16772846
• Report Number: 3009189869-2023-00003
• Device Sequence Number: 14237936
• Product Code: ODP
• UDI-Device Identifier: 00812998020119
• UDI-Public: (01)00812998020119(11)180618
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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: CSTS-MD0707
• Device Catalogue Number: CSTS-MD0707
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2018
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female