MAUDE Adverse Event Report: LIFE SPINE PROLIFT; SHAVER

Model Number	151-268
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The inner shaft of the inserter sheared off when inserting the interbody.
Additional Manufacturer Narrative
It is hypothesized that the root causae of the reported event was insufficient mechanical properties to withstand the impact forces expierced during use.It was identified that the fractures were completely through the threads around the cross pins securing the distal inner shaft to the proximal slap hammer attachment.These impact forces may have been contributed to the failure by off axis loading or a potential tight disc space.
Additional Manufacturer Narrative
The modified hudson paddle shaver was not returned to life spine, therefore, it is not possible to determine what was the root cause of the report event.Based on the description of the reported event, it is hypothesized that the cause of the failure mode was insufficient mechanical properties to withstand the forces that were applied during use, potentially caused by the tight disc space.
Event or Problem Description
While shaving the disc space of a fairly collapsed space, the instrument fractured in two just distally to the shaft.

• Brand Name: PROLIFT
• Common Device Name: SHAVER
• 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: 20539152
• Report Number: 3004499989-2024-00011
• Device Sequence Number: 6773252
• Product Code: MAX
• UDI-Device Identifier: 00190837031091
• UDI-Public: (01)00190837031091
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 151-268
• Device Lot Number: CNW23041
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2023
• 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; Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male