MAUDE Adverse Event Report: Life Spine, Inc. Sentry; Installer

Catalog Number	161-103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
"broken upon impaction.".
Additional Manufacturer Narrative
Visual inspection of the returned device confirmed that the threaded distal tip of the installer was fractured.The distal thread couples the lateral plate to the installer and is subjected to cantilever bending loads during impaction as the plate spikes are driven into the bone.Uneven anatomical surfaces may cause the plate spikes to engage the bone at different times, resulting in asymmetric loading and increased bending stress at the distal threaded connection.Based on the observed fracture and intended use of the device, the failure mode is consistent with fracture of the distal thread due to excessive bending loads during implant insertion, potentially amplified by uneven engagement of the plate spikes with the bone.Due to the age and service history of the device, fatigue damage from repeated use may have been a contributing factor.Fatigue damage would progressively reduce the load bearing capacity of the threaded feature until final fracture occurred during the reported use.

• 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 ; +1(847)884-6117
• MDR Report Key: 50948559
• Report Number: 3004499989-2026-00041
• Device Sequence Number: 9499295
• Product Code: KWQ
• UDI-Device Identifier: 00190837034276
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 161-103
• Device Lot Number: CNW17121R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2018
• 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: 65 YR
• Patient Sex: Male