MAUDE Adverse Event Report: LIFE SPINE PROLIFT WEDGE; INSTALLER

Catalog Number	180-102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the returned device and description of the reported event the expandable wedge installer it's likely that the applied force on the distal tangs during implant insertion and/or manipulation exceeded the mechanical properties of the clamp's distal tangs and resulted in a mechanical fracture of the distal tang.If the user attempted to insert the cage with an excessive amount of force or manipulated the position of the device in the expanded state, this excessive impaction force and post-expansion movement of the implant with the installer after implant is tight in the disc space may place an excessive load on the distal end.In addition, it may have contributed to an angle within the working space that necessitated the need to a torsional force or excessive rocking to remove the installer from the implant after final placement.
Event or Problem Description
It was stated that "tine on the inserter broke off while impacting in.".

• Brand Name: PROLIFT WEDGE
• 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 ; 8478446117
• MDR Report Key: 24489759
• Report Number: 3004499989-2026-00008
• Device Sequence Number: 10681859
• Product Code: MAX
• UDI-Device Identifier: 00190837140779
• UDI-Public: (01)00190837140779(10)CNW21111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203361
• 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): 03/02/2026

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 Catalogue Number: 180-102
• Device Lot Number: CNW21111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 03/02/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female