MAUDE Adverse Event Report: LIFE SPINE SENTRY 2; OSTEOPHYTE REMOVAL TOOL

Model Number	161-109
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is likely that excessive force was applied to the upper clamp tip during removal of a larger and/or dense osteophyte, which exceeded the mechanical strength of the upper law and resulted in overload and this fracture.Additionally, the instrument had been used in multiple surgical procedures since its release prior to the reported event, and cumulative wear from repeated use may have reduced its mechanical strength over time.The combination of increased force required to remove a large or dense osteophyte and potential loss in mechanical strength due to normal wear likely contributed to the fracture of the upper clamp tip.
Event or Problem Description
It was stated that "broke trying to remove the gigantic osteophyte from the lateral spine when we were trying to smooth out the surface to put on the plate.".

• Brand Name: SENTRY 2
• Common Device Name: OSTEOPHYTE REMOVAL TOOL
• 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: 24448751
• Report Number: 3004499989-2026-00007
• Device Sequence Number: 21426004
• Product Code: KWQ
• UDI-Device Identifier: 00190837034245
• UDI-Public: (01)00190837034245
• 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): 02/25/2026

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: 161-109
• Device Lot Number: YH33195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2016
• 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