MAUDE Adverse Event Report: LIFE SPINE, INC. ARX; LOCKING CAP

Catalog Number	148-059
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the description of the reported event and the returned implants, it is hypothesized that the root cause of the reported issue was cross threading the locking caps into the tulip heads.The locking caps exhibited severe signs of damage to the threads which prevented the locking caps from properly interfacing with the tulip head.
Event or Problem Description
It was stated that, "broken screws, set screws.The screws wouldn't set.".

• Brand Name: ARX
• Common Device Name: LOCKING CAP
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22682605
• Report Number: 3004499989-2025-00018
• Device Sequence Number: 9149960
• Product Code: MNI
• UDI-Device Identifier: 00190837031558
• UDI-Public: (01)00190837031558
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 148-059
• Device Lot Number: KH17, KN98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 66 YR
• Patient Sex: Female