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

Catalog Number	EI226004
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Expanding innovations inc., (ei) was notified about a surgery in which the x-pac lateral cage that was implanted into the l4-l5 disc space had, approximately three months post op, subsequently experienced a reduction in height.The surgeon informed ei company representatives that the cage would require removal.
Additional Manufacturer Narrative
Ei's visual inspection of the explanted cage at 10x magnification showed no damage to the locking teeth, nor to any of the other cage components.Functional verification showed that the cage was found to expand and retract as designed.No anomalies were noted on the returned implant that could result in the loss in height of the implant.Review of production records showed that the device lot met all release criteria with no nonconformances reported.Based on the above investigation, the cause of the loss in height cannot be attributed to an implant malfunction.The observed occurrence will continue to be monitored.

• 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, CA 94041 ; 6508613129
• MDR Report Key: 19105751
• Report Number: 3007289746-2024-00001
• Device Sequence Number: 12614323
• Product Code: MAX
• UDI-Device Identifier: 00850041805016
• UDI-Public: 00850041805016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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: EI226004
• Device Lot Number: 20230117-08FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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: 46 YR
• Patient Sex: Male