MAUDE Adverse Event Report: EXPANDING INNOVATIONS, INC. X-PAC; SPINAL CAGE

Catalog Number	EI2511L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An x-pac 10mm x 25mm lordotic cage that was implanted on (b)(6) 2025 on a female patient was reported per (b)(4) to have slipped anteriorly, necessitating a revision surgery on (b)(6) 2025.This is the only patient consequence known to date.
Additional Manufacturer Narrative
An investigation was initiated upon receipt of the complaint.The cage was not available for evaluation, the lot number was not supplied, and no images were provided.The surgeon reported that the explanted cage had subsided slightly into the end plate and subsequently migrated anteriorly.According to the sales representative, the surgeon removed the 10mm x 25mm lordotic tlif/plif expanding innovations cage and replaced it with an alif cage from another manufacturer.In addition, the expanding innovations cage appeared to remain expanded after removal, therefore, it appears to have functioned as intended.As no lot number was supplied, lot history could not be reviewed; however, all cages shipped to customers meet the required specifications prior to release.The exact cause of the cage migration cannot be determined.The deployment, selection, patient condition and anatomy are determined by the surgeon.

• Brand Name: X-PAC
• Common Device Name: SPINAL CAGE
• Manufacturer (Section D): EXPANDING INNOVATIONS, INC.; 110 pioneer way; suite i; mountain view CA 94041
• Manufacturer (Section G): EXPANDING INNOVATIONS, INC.; 110 pioneer way; suite i; mountain view CA 94041
• Manufacturer Contact: amy hurst ; 110 pioneer way; suite i; mountain view, CA 94041 ; 6508613129
• MDR Report Key: 23773940
• Report Number: 3007289474-2025-00002
• Device Sequence Number: 18483015
• Product Code: MAX
• UDI-Device Identifier: 00850001720298
• UDI-Public: 00850001720298
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K201145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/10/2025

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: EI2511L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• 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: 44 YR
• Patient Sex: Female