MAUDE Adverse Event Report: ZAVATION MEDICAL PRODUCTS, LLC ZAVATION EZSPAND SYSTEM; PLIF / TPLIF 9 X 27 X 0DEGREES

Model Number	360-H02700
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Original surgery was (b)(6) 2025.Surgeon reviewed 3 months post op images and noticed that the cage is has backed out of the disc space 1cm approximately.Cage does not look collapsed in image.Patient had subsequent radicular leg pain due to cage position.The patient required explant surgery to remove cage.Surgery took place on (b)(6) 2025.Surgeon is monitoring 2 other patients where cages look to be posterior backing out of disk space but not collapsed.Both patients are assymptomatic.

• Brand Name: ZAVATION EZSPAND SYSTEM
• Common Device Name: PLIF / TPLIF 9 X 27 X 0DEGREES
• Manufacturer (Section D): ZAVATION MEDICAL PRODUCTS, LLC; 3670 flowood drive; flowood MS 39232
• Manufacturer (Section G): ZAVATION MEDICAL PRODUCTS, LLC; 3670 flowood drive; flowood MS 39232
• Manufacturer Contact: elke carter ; 3670 flowood drive; flowood, MS 39232 ; 6019191119
• MDR Report Key: 21877724
• Report Number: 3008583793-2025-00001
• Device Sequence Number: 7899856
• Product Code: MAX
• UDI-Device Identifier: 00842166126480
• UDI-Public: 00842166126480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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 Model Number: 360-H02700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male