MAUDE Adverse Event Report: LIFE SPINE, INC. PROLIFT; INSERTER

Model Number	151-695
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that "both teeth broke off.".
Additional Manufacturer Narrative
Based on the reported event and the returned device, it is hypothesized that during use, an excessive force was applied at an angle to the installer, potentially resulting in a torsional or off-axis asymmetric load (e.G., rocking or toggling) on the distal end of the clamp and outer sleeve components.This off-axis loading likely exceeded the mechanical limites of the distal tangs, leading to their fracture.As the expandable spacer installer is not designed to withstand significant torsional or off-axis forces, an angled insertion maneuver may have caused failure at the distal end of teh installer, resulting in fracture of the clamp's tangs.Complainant reported no patient impact, however, it is reasonable to assume medical or surgical intervention was required to remove the fractured components from the body cavity.Therefore, this mdr is being submitted out of an abundance of caution.

• Brand Name: PROLIFT
• Common Device Name: INSERTER
• 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: 22378421
• Report Number: 3004499989-2025-00014
• Device Sequence Number: 20935228
• Product Code: MAX
• UDI-Device Identifier: 00190837142186
• UDI-Public: (01)00190837142186(10)CNW22021M
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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 Model Number: 151-695
• Device Lot Number: CNW22021M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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 Age: 53 YR
• Patient Sex: Unknown