MAUDE Adverse Event Report: LIFE SPINE SENTRY ALIF; AWL

Model Number	125-603
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "broke during a case".
Additional Manufacturer Narrative
Based on the returned device and additional information it is likely that the distal tip fractured due to material strength being insufficient to withstand the impaction forces generated under a potential off-axis loading condition, in combination with instertion into hard/dense bone and cumulative wear from repeated use over time.

• 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; huntley 60142 ; 8478846117
• MDR Report Key: 24756115
• Report Number: 3004499989-2026-00015
• Device Sequence Number: 21107440
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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 Model Number: 125-603
• Device Lot Number: CNW25021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/01/2026
• 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: 47 YR
• Patient Sex: Female