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

Model Number	PSTS-SM0611-26-SP
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was returned to the manufacturer.Investigation is not yet complete.Review of production records did not indicate any issue related to manufacturing that may have contributed to the event.A supplemental report will be filed as new information becomes available.
Event or Problem Description
The nurse observed the presence of a hair in the sterile blister pack of a 4web posterior spine truss system implant.The nurse decided to open another implant.There was no surgical time added.No patient involvement.

• Brand Name: 4WEB POSTERIOR 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 ; 2801 network boulevard; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 15152808
• Report Number: 3009189869-2022-00005
• Device Sequence Number: 5197516
• Product Code: MAX
• UDI-Device Identifier: 00812998022533
• UDI-Public: (01)00812998022533(17)290501(10)D001R
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K171351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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: PSTS-SM0611-26-SP
• Device Catalogue Number: PSTS-SM0611-26-SP
• Device Lot Number: D001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• 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