MAUDE Adverse Event Report: EXPANDING INNOVATIONS, INC. X-PAC; INTERBODY FUSION DEVICE

Catalog Number	EI2473LT
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device was implanted at l3-l4 on (b)(6) 2025.Intraoperative images provided by the surgeon indicate the cage was partially expanded at the time of deployment.Follow-up imaging obtained on (b)(6) 2025 demonstrates a reduction in cage height.The device remains implanted in this condition.Per the surgeon, the patient has demonstrated continued clinical improvement and reported satisfaction at follow-up visits on (b)(6) 2025 and (b)(6) 2026.The event was reported to ei by the surgeon during a routine follow-up communication on (b)(6) 2026.
Additional Manufacturer Narrative
Expanding innovations was notified that a cage used in a tlif procedure showed reduced height postoperatively.The surgery was performed on (b)(6) 2025.A 12 mm × 32 mm lordotic tall implant (ei2473lt) was placed at l3-l4 and appeared expanded approximately 2 mm in postoperative images.The patient is reported to be doing well, and the surgeon has indicated no further intervention is required.As the cage will not be removed, imaging is the only available data, and no additional analysis is possible.

• Brand Name: X-PAC
• Common Device Name: INTERBODY FUSION DEVICE
• 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: mbithi muthini ; 110 pioneer way, suite i; mountain view, CA 94041
• MDR Report Key: 24760408
• Report Number: 3007289746-2026-00001
• Device Sequence Number: 15742850
• Product Code: MAX
• UDI-Device Identifier: 00850001720250
• UDI-Public: 00850001720250
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K152539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EI2473LT
• Device Lot Number: UNKNOWN
• 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: 03/02/2026
• Initial Report FDA Received Date: 04/01/2026
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White