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

Model Number	PSTS-SM0010-26-SP
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs provided to confirm the alleged event.
Event or Problem Description
It was reported the implant migrated post-operatively.The company was notified that the patient required a revision surgery.No complications were reported to the manufacturer.The patient is doing well post-operatively.

• 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
• MDR Report Key: 8303209
• Report Number: 3009189869-2019-00003
• Device Sequence Number: 19248252
• Product Code: MAX
• UDI-Device Identifier: 00812998022410
• UDI-Public: (01)00812998022410(17)210101(10)A004
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: PSTS-SM0010-26-SP
• Device Catalogue Number: PSTS-SM0010-26-SP
• Device Lot Number: A004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Distributor Facility Aware Date: 02/05/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR