MAUDE Adverse Event Report: LIFE SPINE PROLIFT; INSERTER

Model Number	L151-596
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated "distal tip of inserter broke off.".
Additional Manufacturer Narrative
The installer was not returned, therefore it is not possible to determine what was the failure mode resulting in the event.However, based on the description and additional information provided, it is hypothesized excessive impaction force was applied to the installer during use, potentially resulting in a torsional or off-axis asymmetric load (rocking or toggling) being applied to the distal tip of the installer, this may have led to a mechancial fracture of the tang.As expandable spacer installers are not designed to withstand excessive torsional or off-axis loads, an insertion force applied at an angle could have caused the failure are the distal tip.

• Brand Name: PROLIFT
• Common Device Name: INSERTER
• 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: 24742954
• Report Number: 3004499989-2026-00013
• Device Sequence Number: 21025822
• Product Code: MAX
• UDI-Device Identifier: 00190837117610
• UDI-Public: (01)00190837117610(10)CNW22072
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: L151-596
• Device Lot Number: CNW22072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• 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
• Patient Sex: Unknown