MAUDE Adverse Event Report: LIFE SPINE INC. PROLIFT; INSTALLER

Catalog Number	L151-596
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited description of the reported event and that the reported instruments have not been returned, at this time it is not possible to determine the root cause of the reported event or to conifrm that the device(s) failed to meet specifications.
Event or Problem Description
It was stated that, " two broken prolift expandable installers that broke.One broke during insertion and the other came apart afterwards.No harm to patient or delay of case.No component left in patient.".

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• Manufacturer (Section D): LIFE SPINE INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s. quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22962829
• Report Number: 3004499989-2025-00022
• Device Sequence Number: 18615417
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610(10)CNW22011
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/03/2025

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 Catalogue Number: L151-596
• Device Lot Number: CNW22011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2022
• 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: Required Intervention
• Patient Sex: Unknown