MAUDE Adverse Event Report: LIFE SPINE, INC. AVATAR; INSERTER

Model Number	116-002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "in today's case one of the sides of the attachment that holds the rod in place, came off when [doctor] was trying to advance the rod further into the tulip.Patient was not harmed.".
Additional Manufacturer Narrative
Based on the description of the reported event and returned device, it is hypothesized that the root cause of the reported event was insufficient mechanical properties of the instrument's distal tip to withstand the applied forces.It is likely that while advancing the attached rod within the working space, potentially requiring torsional force or rocking, an excessive or off-axis load caused excessive stress on the distal tip, ultimately leading to its fracture.

• Brand Name: AVATAR
• Common Device Name: INSERTER
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 qualtiy drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22420593
• Report Number: 3004499989-2025-00017
• Device Sequence Number: 7138539
• Product Code: NKB
• UDI-Device Identifier: 00190837171889
• UDI-Public: (01)00190837171889(10)CNW24071
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111953
• 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): 07/07/2025

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 Model Number: 116-002
• Device Lot Number: CNW24071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/07/2025
• 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: 30 YR
• Patient Sex: Male