MAUDE Adverse Event Report: LIFE SPINE SOLSTICE; SCREW

Model Number	9435-12
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw size was mislabeled, the rest of inventory was verfied to be accurate.
Event or Problem Description
It was stated that "one of the (9435-12) 3.5 x 12 solstice restock screws was incorrectly sized and labeled.It was labeled a 3.5 x 12mm screw on the actual screw and packaging but i noticed it looked a little too long to be a 12mm screw.When i measured it on the caddy you can see the screw is actually a 14mm screw length.One of the towers from the solstice system is stuck in its fully compressed position and can not be backed out because it is jammed".

• Brand Name: SOLSTICE
• 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: 22029827
• Report Number: 3004499989-2025-00006
• Device Sequence Number: 15541451
• Product Code: KWP
• UDI-Device Identifier: 00190837024673
• UDI-Public: (01)00190837024673(10)KS89
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial

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: Other
• Device Model Number: 9435-12
• Device Lot Number: KS89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 05/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown