MAUDE Adverse Event Report: Zavation Medical Products, LLC eZspand Expandable Interbody System; PLIF/T-PLIF interbody fusion devices

Model Number	360-M1132-10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury

• Brand Name: eZspand Expandable Interbody System
• Common Device Name: PLIF/T-PLIF interbody fusion devices
• Manufacturer (Section D): Zavation Medical Products, LLC; 3670 flowood dr; flowood MS 39232
• Manufacturer (Section G): Zavation Medical Products, LLC; 3670 flowood dr; flowood 39232
• Manufacturer Contact: elke carter ; 3670 flowood dr; flowood, MS 39232 ; +1(601)919-1119
• MDR Report Key: 50905612
• Report Number: 3008583793-2026-00005
• Device Sequence Number: 10761627
• Product Code: MAX
• UDI-Device Identifier: 00842166146389
• UDI-Public: 00842166146389
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K191339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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-M1132-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Male