MAUDE Adverse Event Report: Life Spine, Inc. ProLift; Screwdriver

Catalog Number	L151-889
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to insufficient information regarding the reported event and the device not being returned for evaluation, the root cause of the reported failure cannot be definitively determined.Based on the device history and the mechanical properties of the material and geometry, failure of the t15 drive feature due solely to torsional overload during implant expansion would not be expected when using a properly functioning intended 2in-lbs torque limiting handle.If the reported failure occurred as a result of torsional overload during implant expansion, the investigation findings suggest that the intended torque limiting handle was likely not used or did not limit the applied torque as intended.
Event or Problem Description
"prolift 8mm screwdriver tip broke while expanding cage.".

• Brand Name: ProLift
• Common Device Name: Screwdriver
• Manufacturer (Section D): Life Spine, Inc.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; +1(847)884-6117
• MDR Report Key: 50715562
• Report Number: 3004499989-2026-00038
• Device Sequence Number: 21492850
• Product Code: MAX
• UDI-Device Identifier: 00190837200329
• UDI-Public: (01)00190837200329
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K250373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: L151-889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown