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

Catalog Number	EI2473LT
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After inspection of the returned device, the loss in expansion is attributed to an implant that was damaged following manipulation of the cage prior to implantation.The previously damaged implant likely resulted in the difficult attachment to the instrument as had been reported at the beginning of the case.When one of the critical components of the cage is damaged prior to implantation, the cage's ability to function properly is compromised and loss of expansion could occur.The ifu states all implants should be carefully examined for completeness and damage, prior to use.
Event or Problem Description
Expanding innovations was notified that a 2 level tlif procedure had used a 12x32 lordotic implant which exhibited an intra-op reduction in height after expansion.The scrub tech reported having difficulty assembling the cage/cannula/inserter system.The cage was inserted by the surgeon and expanded.Intra-op images taken during the procedure showed the reduction in expansion after initial expansion.

• Brand Name: X-PAC
• Common Device Name: INTERVERTEBRAL BODY 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
• MDR Report Key: 22954894
• Report Number: 3007289746-2025-00001
• Device Sequence Number: 8529814
• Product Code: MAX
• UDI-Device Identifier: 00850001720250
• UDI-Public: 00850001720250
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152539
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: EI2473LT
• Device Lot Number: 20210209-03FA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male