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

Model Number	PSTS-SM0608-26-SP
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs were provided and showed the device had migrated posteriorly.Comments from surgeon indicated that the patient's bone condition was poor and the posterior pedicle screws had loosened resulting in the migration which led to the revision.The construct was no longer stable due to the pedicle screw loosening and the migration was a secondary result.The surgeon does not believe the 4web interbody fusion cage was the cause of the need to revise.
Event or Problem Description
It was reported that during the patient's 6-week follow-up it was found that the implant migrated posteriorly.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.It is unknown which device is related to the reported incident.Therefore, both devices are being reported.(device 2 of 2).

• 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: 8404425
• Report Number: 3009189869-2019-00005
• Device Sequence Number: 13946944
• Product Code: MAX
• UDI-Device Identifier: 00812998022502
• UDI-Public: (01)00812998022502(17)211101(10)D003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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: 11/01/2021
• Device Model Number: PSTS-SM0608-26-SP
• Device Catalogue Number: PSTS-SM0608-26-SP
• Device Lot Number: D003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2019
• Initial Report FDA Received Date: 03/08/2019
• 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: 63 YR