MAUDE Adverse Event Report: LIFE SPINE INC PROLIFT LATERAL; INSTALLER

Catalog Number	151-1716
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "it broke during the case today when [the doctor] was malletting.".
Additional Manufacturer Narrative
Based on the reported event and the returned device, it is likely that the cause of the failure was insufficient mechanical properties to withstand the impact force that was applied during use.The excessive impaction forces that were reported may have exceeded the mechanical properties due to potential off axis loading or a tight disc space and this may have been contributed to from wear on the device over previous repeated uses.

• Brand Name: PROLIFT LATERAL
• 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: 23033512
• Report Number: 3004499989-2025-00025
• Device Sequence Number: 21258034
• Product Code: MAX
• UDI-Device Identifier: 00190837155353
• UDI-Public: (01)00190837155353(10)CNW23031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191005
• 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): 09/11/2025

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: 151-1716
• Device Lot Number: CNW23031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 74 YR
• Patient Sex: Female