MAUDE Adverse Event Report: 4WEB, INC. 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE

Model Number	ASTS-SA-100014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to the manufacturer that surgeon had issues re-engaging an anterior spine truss system - stand alone freehand inserter into the cage to reposition it.This led to over sixty minutes of additional surgical time.No injury to patient was reported.Surgery was completed successfully.
Additional Manufacturer Narrative
Product was not returned to the manufacturer as it was reported to be discarded.The production records were reviewed based on the part and lot number information provided.No manufacturing deviations were identified that could have contributed to this event.The exact cause of this event could not be established.The event was reported to have occurred in ecuador.

• Brand Name: 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE
• 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: 20025630
• Report Number: 3009189869-2024-00014
• Device Sequence Number: 7336054
• Product Code: OVD
• UDI-Device Identifier: 00812998043989
• UDI-Public: (01)00812998043989(10)30402-R
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K200002
• 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): 08/20/2024

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-SA-100014
• Device Catalogue Number: ASTS-SA-100014
• Device Lot Number: 30402-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown