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

Model Number	PSTS-SM0610-22-SP
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation.Radiographs were provided that showed the device had migrated posteriorly.Review of production records did not indicate any issues related to manufacturing that may have contributed to the event.
Event or Problem Description
It was reported that the patient required an initial revision surgery two days after the original surgery, where the implant was repositioned since it was observed that it had migrated.About 45 days following the first revision surgery, it was observed by the surgeon that the implant had migrated posteriorly again.A second revision surgery was performed where the implant was removed from the patient and replaced with bone graft.No complications were reported to the manufacturer.

• 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: 9112385
• Report Number: 3009189869-2019-00013
• Device Sequence Number: 19638122
• Product Code: MAX
• UDI-Device Identifier: 00812998022304
• UDI-Public: (01)00812998022304(17)210701(10)D001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 07/01/2021
• Device Model Number: PSTS-SM0610-22-SP
• Device Catalogue Number: PSTS-SM0610-22-SP
• Device Lot Number: D001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• 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: 51 YR