MAUDE Adverse Event Report: LIFE SPINE PROLIFT; EXANDABLE INTERBODY

Model Number	58-1028-1210K
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that " the first implant we used we had to wastes due to it not expanding.".
Additional Manufacturer Narrative
Based on the returned device condition and the additional information receive, it is possible unintended actuation in the collapsed direction occured during use, which may have resulted in over-collapsing the implant.This condition could have led to misalignment (mistiming) of the cephalad and caudel endplates relative to the internal components which will then seize the implant and prevent further expansion.

• Brand Name: PROLIFT
• Common Device Name: EXANDABLE INTERBODY
• 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: 24753966
• Report Number: 3004499989-2026-00014
• Device Sequence Number: 10102129
• Product Code: MAX
• UDI-Device Identifier: 00190837086527
• UDI-Public: (01)00190837086527(17)280605(10)CT215993
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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
• Device Model Number: 58-1028-1210K
• Device Lot Number: CT215993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male