MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSTALLER

Model Number	L151-690
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the reported event and the returned devices, it is hypothesized that during use, as excessive force applied to the installers at an angle during use, resulting in torsional or off-axis asymmetric load (ie rocking or toggling) being applied to the distal end of the clamp and outer sleeve components.
Event or Problem Description
Prolift inserted x2 teeth broke during insertion of cage.No component left in patient.

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• 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: 21566860
• Report Number: 3004499989-2025-00001
• Device Sequence Number: 17236617
• Product Code: MAX
• UDI-Device Identifier: 00190837138974
• UDI-Public: (01)00190837138974(10)CNW23031
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: L151-690
• Device Lot Number: CNW23031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/10/2025
• 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: Other
• Patient Sex: Unknown