MAUDE Adverse Event Report: LIFE SPINE INC. SENTRY; INSTALLER

Model Number	169-104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anterior plate installer was not returned to life spine; therefore, it is not possible to determine the exact root cause of the reported event.However, based on the image and information provided, it is likely that the failure occurred due to improper instrument handling.It is hypothesized that the surgeon attempted to lift the shaft of the installer while the threaded tip was still engaged with the plate to create space for awl usage.This likely placed excessive bending or shear forces on the threaded tip resulting in mechanical failure.
Event or Problem Description
It was stated that, "during our case last monday (b)(6), the threaded inserter of the sentry plate holder broke during our case.The tip of the inserter broke off while using the awl on the plate, however it stayed partially threaded in to the plate and they just took the plate out of the body cavity.".

• Brand Name: SENTRY
• Common Device Name: INSTALLER
• Manufacturer (Section D): LIFE SPINE INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22125927
• Report Number: 3004499989-2025-00009
• Device Sequence Number: 12633383
• Product Code: KWQ
• UDI-Device Identifier: 00190837034597
• UDI-Public: (01)00190837034597
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 169-104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/02/2025
• 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 Age: 53 YR
• Patient Sex: Male