MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSTALLERS

Catalog Number	L151-690, L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "distal tip of prolift inserter broke off at l4-l5.2 inserters broke; collapsed disc space, shaved to an 8 only.".
Additional Manufacturer Narrative
Based on the reported event and the returned devices, it is hypothesized that during use, an excessive force was applied to the installers at an angle due to patient anatomy and limited working space (l4-l5), resulting in a torsional or off-axis asymmetric load (e.G., rocking or toggling) being applied on the distal end of the clamp components.Since expandable spacer installers are not designed to withstand excessive torsional or off-axis loads, an angled insertion force may have led to a fracture of the clamp component's tangs.

• Brand Name: PROLIFT
• Common Device Name: INSTALLERS
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 23290856
• Report Number: 3004499989-2025-00028
• Device Sequence Number: 20029616
• Product Code: MAX
• UDI-Device Identifier: 00190837154011
• UDI-Public: (01)00190837154011(10)CNW23031
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/07/2025

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: L151-690, L151-596
• Device Lot Number: CNW23031, CNW20101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 84 KG