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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 320256911
• Report Number: 3009189869-2023-00008
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00812998045075
• UDI-Public: (01)00812998045075(17)280501(10)D004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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