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

Model Number	ASTS-000007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for investigation and the tip break was confirmed.The production records were reviewed, no manufacturing deviations were identified that could have contributed to this event.The exact cause of this event could not be established.
Event or Problem Description
It was reported to the manufacturer that threaded portion of an alif inserter sheared off in the cage during implant impaction/insertion.The inserter tip was left in cage, inside the patient.No injury to patient was reported.Surgery was completed successfully.

• Brand Name: 4WEB ANTERIOR SPINE TRUSS SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 20163489
• Report Number: 3009189869-2024-00016
• Device Sequence Number: 20658158
• Product Code: MAX
• UDI-Device Identifier: 00812998034024
• UDI-Public: (01)00812998034024(10)B8957
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASTS-000007
• Device Catalogue Number: ASTS-000007
• Device Lot Number: B8957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female