MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSTALLER

Model Number	L151-695
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the event description, it is hypothesized that an applied fouce on the distal tangs during implant manipulation or disengaging the installer from the implant exceeded the mechanical properties of the distal tangs during its last use.If the user attempted to manipulate the position of the device in the expanded state, this post-expansion movement within a tight disc space may place an excessive load on the distal tangs of the installer.Also, the angle and potential rocking movement put excessive stress load on the installer's distal tangs.Additionally, impacting the installer while the driver was engaged could have led to a bottomed-out interference that could have resulted in the tang fracturing off.
Event or Problem Description
Tips from short10/12mm inserter broke insitu.Surgeon was able to retrieve the broken tips using the suction, so nothing was retained in the patient.

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 24201591
• Report Number: 3004499989-2026-00005
• Device Sequence Number: 14823712
• Product Code: MAX
• UDI-Device Identifier: 00190837142254
• UDI-Public: (01)00190837142254
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: L151-695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• 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: Required Intervention
• Patient Sex: Unknown