MAUDE Adverse Event Report: LIFE SPINE ARX SAI; SCREW

Model Number	18-8590-09
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the description of the reported event, no device failure occured.The screw uses the identical head as the other implanted screw and provides a equivalent cone of angulation.During the procedure, the surgeon experienced difficulty aligning the rod within the full construct to connect with the anchoring screws.As a result, the screws were removed and replaced with another screw from the same family.
Event or Problem Description
It was stated that the dr.Was having a very difficult time lining up the rod to all of the tulip heads and everything would be aligned but two screws,explanted the two screws.

• Brand Name: ARX SAI
• Common Device Name: SCREW
• 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: 24816955
• Report Number: 3004499989-2026-00016
• Device Sequence Number: 6027745
• Product Code: NKB
• UDI-Device Identifier: 00190837175214
• UDI-Public: (01)00190837175214
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K241464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 18-8590-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male