MAUDE Adverse Event Report: LIFE SPINE INC. TRULIFT; INTERBODY

Catalog Number	68-1028-1210
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "[the doctor] just sent me intra-op and post op photos of a trulift that appears to have collapsed in height.This did not happen in a case.It was noticed in a post op follow up.".
Additional Manufacturer Narrative
The trulift, 10mm x 28mm x 10mm - 16mm, 12° was unable to be returned to life spine; therefore, it is not possible to determine the complete failure mode that resulted in the reported event.However, based on the description of the event and the provided fluoroscopy images, it is hypothesized that the cause of this failure was likely the application of excessive torsional forces, potentially over torquing the interbody which may be attributed to user error.This excessive force during implant expansion could have compromised the interbody's ability to maintain the desired mechanical strength.When expanding the implant, the specified torque-limiting handle should be used to control the amount of distraction force generated by the implant and to minimize the risk associated with over-torquing the interbody.

• Brand Name: TRULIFT
• Common Device Name: INTERBODY
• Manufacturer (Section D): LIFE SPINE INC.; 13951 s quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s quality drive; huntley, IL 60142 ; 8478876117
• MDR Report Key: 23316105
• Report Number: 3004499989-2025-00030
• Device Sequence Number: 5135230
• Product Code: MAX
• UDI-Device Identifier: 00190837097325
• UDI-Public: (01)00190837097325(17)260706(10)KD04
• Combination Product (Y/N): N
• 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): 10/16/2025

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 Catalogue Number: 68-1028-1210
• Device Lot Number: KD04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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: 59 YR
• Patient Sex: Male