MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSTALLER

Model Number	151-697
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was stated that "while inserting of a 8x28x8-13mm, 12° prolift the cage was expanded and upon disengagement and removal of inserter an audible click was heard and surgeon identified that the distal tip of the inserter had broken off.A different inserter was used to collapse the cage and remove it.Upon removal an x-ray was taken and the broken aspect was seen in the disc space.Surgeon was able to retrieve the broken piece and remove.Cage was then successfully implanted and expanded".
Additional Manufacturer Narrative
The device was not returned it is hypothesized that during its last use there was an applied force on the distal tangs during implant disengagement that exceeded the mechanical properties.Aggressive rocking or manipulation of the driver to disengage the implant could have generate enough force to break the tangs.

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22005791
• Report Number: 3004499989-2025-00003
• Device Sequence Number: 13040078
• Product Code: MAX
• UDI-Device Identifier: 00190837142209
• UDI-Public: (01)00190837142209(10)CNW21101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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: 151-697
• Device Lot Number: CNW21101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (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: 58 YR
• Patient Sex: Male