MAUDE Adverse Event Report: 4WEB, INC. 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	ASTS-SA-LG1612-SP
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer that upon opening the first outer blister seal and proceeding to open the inner blister of a sterile packaged implant, it was noticed that a part of the external pull tab was loose from the seal.Another sterile implant was opened to continue with the surgery.There was no impact to the surgery and there was no patient involvement.
Additional Manufacturer Narrative
Product was returned to the manufacturer.Investigation is not yet complete.Review of production records did not indicate any issues related to manufacturing that may have contributed to the event.A supplemental report will be filed as new information becomes available.
Additional Manufacturer Narrative
The innner blister seal was found to be intact.This is an isolated incident for broken blister seal.As part of investigation, a seal-strength test was performed on the returned product and the result was found to be acceptable.The exact cause of device problem could not be established.

• Brand Name: 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: 17445947
• Report Number: 3009189869-2023-00008
• Device Sequence Number: 2598475
• Product Code: OVD
• UDI-Device Identifier: 00812998045075
• UDI-Public: (01)00812998045075(17)280501(10)D004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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
• Device Model Number: ASTS-SA-LG1612-SP
• Device Catalogue Number: ASTS-SA-LG1612-SP
• Device Lot Number: D004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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 Sex: Unknown