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

Catalog Number	L151-690
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the returned device, it is hypothesized that during use an excessive force was applied to the installer at an angle which resulted in a torsional or off-axis asymmetric (e.G., rocking or toggling) load being applied to the distal tip of the installer.As expandable spacer installers are not designed to withstand an excessive torsional or off-axis load, an insertion force applied at an angle may have resulted in the failure at the distal arm of the installer.If movement of the implant is needed after it has been expanded in the disc space, the implant should be collapsed to allow for the movement and then re-expanded in the desired location.In addition, the expansion driver should remain in place (or be replaced) to assist the installer in maintaining alignment while being removed.
Event or Problem Description
It was stated, "it broke up surgeon using a mallet and trying to inserter cage into a collapse disc space.Broken piece was recovered.".

• Brand Name: PROLIFT
• Common Device Name: INSERTER
• 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: 22900044
• Report Number: 3004499989-2025-00021
• Device Sequence Number: 18366882
• Product Code: MAX
• UDI-Device Identifier: 00190837154011
• UDI-Public: (01)00190837154011(10)CNW23031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/26/2025

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: CNW23031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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