MAUDE Adverse Event Report: LIFE SPINE, INC. PROLIFT; INSERTER

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the returned device, it is likely that the root cause of the failure mode was insufficient mechnical properties to withstand the impaction forces that were applied during its last use.The impact forces may have exceeded the mechanical properties due to potential off axis loading or a tight disc space.In addition, the installer featured some rust propagation, indicating the instrument was likely left wet following sterilization for an extended duration.This rust likely exacerbated the compromise of the specific joint, contributing to the fracture seen.
Event or Problem Description
It was stated that, "the prolift inserter inner mechanism snapped in half.No component left in patient.Reported delay: 3 mins.The surgeon was malleting the interbody into the disc space.".

• Brand Name: PROLIFT
• Common Device Name: INSERTER
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22366690
• Report Number: 3004499989-2025-00013
• Device Sequence Number: 15811714
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610(10)CNW21091M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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 Model Number: L151-596
• Device Lot Number: CNW21091M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown