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

Model Number	PSTS-SM0609-26-SP
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation nor were radiographs provided.Review of production records did not indicate any issue related to manufacturing that may have contributed to the event.The cause of the event could not be established with the information available to the manufacturer.
Event or Problem Description
During six-week post-op follow-up after the original surgery l5-s1, the surgeon identified that one of two implanted cages had migrated into the canal.The patient also reported pain.The surgeon performed a revision surgery to explant the cage.It is unknown which of the two implanted cages is related to the reported incident.Therefore, both the devices are being reported (device 1 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
• MDR Report Key: 10186630
• Report Number: 3009189869-2020-00010
• Device Sequence Number: 16370805
• Product Code: MAX
• UDI-Device Identifier: 00812998022519
• UDI-Public: (01)00812998022519(17)220401(10)D001
• Combination Product (Y/N): N
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 04/01/2022
• Device Model Number: PSTS-SM0609-26-SP
• Device Catalogue Number: PSTS-SM0609-26-SP
• Device Lot Number: D001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/23/2020
• 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: 64 YR
• Patient Weight: 127