MAUDE Adverse Event Report: Life Spine, Inc. ProLift; Installer

Catalog Number	L151-690
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
"tang broke off".
Additional Manufacturer Narrative
Due to insufficient information regarding the reported event and the device not being returned for evaliation, the root cause of the reported failure cannot be definitively determined.Based on the device history, the fractured distal tip is hypothesized to have resulted from excessive loading during use or combination of fatigue damage from repeated usage that reduced the device's mechanical load capacity.Failures of the tip are typically caused by torsional and bending stresses generated during implant repositioning or excessive rocking to disengage the installer.It is recommended to collapse the implant prior to repositioning to reduce the stress on the instruments distal tip.

• 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 ; +1(847)884-6117
• MDR Report Key: 50775459
• Report Number: 3004499989-2026-00039
• Device Sequence Number: 9472245
• Product Code: MAX
• UDI-Device Identifier: 00190837154011
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Catalogue Number: L151-690
• Device Lot Number: CNW23041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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