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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event and returned device, it is hypothesized that an excessive impaction force was applied to the installer during use, potentially resulting in a torsional or off-axis asymmetric load (e.G., rocking or toggling) being applied to the distal tip of the installer.This may have led to a mechanical failure of the tang.As expandable spacer installers are not designed to withstand excessive torsional or off-axis loads, an insertion force applied at an angle could have caused failure at the distal tip.
Event or Problem Description
It was stated that, "tip of inserter broke during insertion.".

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• Manufacturer (Section D): LIFE SPINE INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s. quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22749453
• Report Number: 3004499989-2025-00019
• Device Sequence Number: 20984261
• Product Code: MAX
• UDI-Device Identifier: 00190837154011
• UDI-Public: (01)00190837154011(10)CNW23041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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
• Device Lot Number: CNW23041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/08/2025
• 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: Required Intervention
• Patient Sex: Unknown