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

Catalog Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was state that, "long prolift inserter tip fractured after acge was implanted and surgeon was attempting to disengage the inserter.The broken piece of the tip was sucked into the neptume and confirm to be there and not in the patient by the nurse.".
Additional Manufacturer Narrative
Based on the returned device, it is likely that there was an applied force on the distal tang while disengaging the installer from the implant that exceeded the mechanical properties of the distal tip.There may have been an angle within the working space that necessitated the need for torsional force or excessive rocking to remove the installer from the implant after final placement, which could have resulted in an excessive stress load experienced on the installer's distal tang.It is also possible that the distal tangs were not fully splayed prior to instrument removal which would cause material interference and prevent the installer from easily releasing off the implant.

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• 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: 23350411
• Report Number: 3004499989-2025-00032
• Device Sequence Number: 7956828
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610(10)CNW20121
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: CNW20121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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