MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The prolift expandable spacer installer was not returned to life spine despite attempts to retrieve, therefore, the reported event could not be confirmed or fully evaluated.Based on the description of the reported event, it is hypothesized that an applied force on the distal tang during implant manipulation or disengaging the installer from the implant exceeded the mechanical properties of the distal tang during its last use.Based on the potential failure, it is hypothesized that during its last 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.Additionally, impacting on the system while the driver was engaged could have led to a bottomed-out interference that could have resulted in the tangs fracturing off.
Event or Problem Description
It was stated, "prolift 10/12mm expandable spacer installer broke off during interbody insertion.No component left in patient.The fractured component fell into the patient's body and was successfully retrieved.".

• Brand Name: PROLIFT
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478886117
• MDR Report Key: 22179568
• Report Number: 3004499989-2025-00011
• Device Sequence Number: 9739698
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: L151-596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/10/2025
• 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: Required Intervention
• Patient Sex: Unknown