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

Catalog Number	151-695
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event and the returned device, it is hypothesized that an excessive impaction force was applied to the installer during use, potentially resulting in a torsional or off-axis asymmetric load ( e.G., rocking or toggling) being applied to the distal tip of the installer.This may have led to a mechanical 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 failure at the distal tip.If movement of the implant is needed after it has been expanded in the disc space, the implant should be collapsed to allow for the movement and then re-expanded in the desired location.In addition, the expansion driver should remain in place (or be replaced) to assist the installer in maintaining alignment while being removed.
Event or Problem Description
It was stated that, "as [the doctor] was impacting the inserter the clamp on the left side broke off.".

• Brand Name: PROLIFT
• Common Device Name: INSTALLER
• Manufacturer (Section D): LIFE SPINE INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 24606883
• Report Number: 3004499989-2026-00012
• Device Sequence Number: 8895299
• Product Code: MAX
• UDI-Device Identifier: 00190837142186
• UDI-Public: (01)00190837142186(10)CNW22021M
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/16/2026

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: 151-695
• Device Lot Number: CNW22021M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male