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

Catalog Number	L151-695
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that "tip of inserter broke off.".
Additional Manufacturer Narrative
Based on the returned device, it is hypothesized that there was an applied torsional load during its last use that exceeded the mechanical properties of the clamp's distal tang.If the user attempted to manipulate the position of the implant in the expanded state, it may have placed an excessive load on the clamp.In addition, it may have contributed to an angle within the working space that necessitated the need for torsional force or excessive rocking to remove the installer from the implant after final placement.

• 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: 22833149
• Report Number: 3004499989-2025-00020
• Device Sequence Number: 15872310
• Product Code: MAX
• UDI-Device Identifier: 00190837142254
• UDI-Public: (01)00190837142254(10)CNW22021
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/18/2025

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: L151-695
• Device Lot Number: CNW22021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/18/2025
• 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