MAUDE Adverse Event Report: ZAVATION MEDICAL PRODUCTS, LLC EZSPAND CAGE; PLIF/T-PLIF EXPANDIBLE CAGE 9X23X10°, 8.5-13MM

Catalog Number	360-M092310
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Cage appears to be collapsing on post operative x-rays, foot drop presented at 2 weeks post op.Further decommession performed and fixed any symptoms.

• Brand Name: EZSPAND CAGE
• Common Device Name: PLIF/T-PLIF EXPANDIBLE CAGE 9X23X10°, 8.5-13MM
• Manufacturer (Section D): ZAVATION MEDICAL PRODUCTS, LLC; flowood dr.; flowood MS 39232
• Manufacturer (Section G): ZAVATION MEDICAL PRODUCTS, LLC; 3670 flowood dr; flowood MS 39232
• Manufacturer Contact: elke carter ; 3670 flowood dr.; flowood, MS 39232 ; 6019191119
• MDR Report Key: 22879199
• Report Number: 3008583793-2025-00004
• Device Sequence Number: 10371595
• Product Code: MAX
• UDI-Device Identifier: 00842166146303
• UDI-Public: 00842166146303
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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 Catalogue Number: 360-M092310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/22/2025
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Female