MAUDE Adverse Event Report: LIFE SPINE SENTRY ALIF; AWL

Catalog Number	125-603
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the returned device fixed awl and the reported event, it is likely that the distal tip expierenced loading that exceeded its mechanical strength during use.A potential contributing factor to this failure was likely off-axis loading.It is hypothesized that the device may have been used at a steep angle, which could have misaligned the applied force along the shaft and introduced off-axis, levering force at the dital tip.Additionally, higher insertion resistance (e.G.Dense/hard bone) and normal wear from repeated use may have further increased the stress on the distal tip and contributed to the fracture.
Event or Problem Description
It was stated, "it broke in the vertebral body while being inserted to make the pilot hole for the screw.Yes the broken piece was removed by heavy needle driver".

• Brand Name: SENTRY ALIF
• Common Device Name: AWL
• 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: 24519494
• Report Number: 3004499989-2026-00010
• Device Sequence Number: 9724703
• Product Code: KWQ
• UDI-Device Identifier: 00190837043247
• UDI-Public: (01)00190837043247
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180166
• 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): 03/05/2026

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: 125-603
• Device Lot Number: CNW25021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/05/2026
• 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: 59 YR
• Patient Sex: Male