MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSERTER

Model Number	L151-690
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated "prolift inserter inner core broke while inserting cage into patient, we had to find a way to wiggle out the cage inserter while it was inserted in the patient as it no longer had a handle on it and need to pop off from the cage.".
Additional Manufacturer Narrative
It was observed that the fracture occured completely through the cross pins that secure the distal inner shaft to the proximal slap hammer attachment.It is believed that the fracture occured around the cross pin and propgated along the threads.

• Brand Name: PROLIFT
• Common Device Name: INSERTER
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 25004522
• Report Number: 3004499989-2026-00019
• Device Sequence Number: 12967302
• Product Code: MAX
• UDI-Device Identifier: 00190837154011
• UDI-Public: (01)00190837154011(10)CNW23041
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: L151-690
• Device Lot Number: CNW23041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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