MAUDE Adverse Event Report: LIFE SPINE TRULIFT; EXPANDABLE CAGE

Model Number	68-1028-1508 & 68-1028-1210
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was stated that, i recieved a text from the dr.Today about a collapsed trulift and migrated trulift same patient.
Additional Manufacturer Narrative
Based on the description of the reported event and the provided fluoroscopy images, the exact cause leading to the reported device collapse and migration cannot be definitively determined.An internal investigation was initiated, however, the reported condition could not be replicated during investigation.Additionally, no information was provided regarding the surgical technique used, the type of torque handle utilized, the amount of torque applied during implantation.The absence of this information limits the ability to further assess contributing factors associated with the reported event.

• Brand Name: TRULIFT
• Common Device Name: EXPANDABLE CAGE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 23927259
• Report Number: 3004499989-2025-00035
• Device Sequence Number: 18333858
• Product Code: MAX
• UDI-Device Identifier: 00190837097332
• UDI-Public: (01)00190837097332(17)260720(10)KC41
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201721
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2026
• Device Model Number: 68-1028-1508 & 68-1028-1210
• Device Lot Number: KC41 & KD04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male